Dose measurement systems and methods

ABSTRACT

Embodiments described herein generally relate to devices, systems and methods for measuring a volume or number of doses remaining in a drug delivery device that is used for delivering a dose to a patient. In some embodiments, a dose measurement system for measuring the liquid volume in a container includes a light guide disposed and configured to reflect electromagnetic radiation toward the container. The dose measurement system also includes a light guide disposed and configured to emit electromagnetic radiation into the light guide. A plurality of sensors are located in the apparatus that are optically coupleable to the light guide and are disposed and configured to detect the electromagnetic radiation emitted by at least a portion of the light guide. The apparatus also includes a processing unit configured to receive data representing the portion of the detected electromagnetic radiation from each of the plurality of sensors. The processing unit is further operable to convert the received data into a signature representative of the electromagnetic radiation detected by the plurality of sensors.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the priority benefit, under 35 U.S.C. § 119(e),of U.S. Application No. 62/362,946, entitled “Dose Measurement Systemsand Methods,” filed on Jul. 15, 2016, the disclosure of which isincorporated herein by reference in its entirety.

BACKGROUND

Embodiments described herein relate generally to devices, systems, andmethods for measuring a quantity of a liquid disposed in a container,and in particular to measuring a volume or number of doses remaining ina drug delivery device.

Many chronic disease patients are prescribed medications that need to beself-administered, administered by a caregiver, or administered by anautomated or semi-automated delivery system using injection pens orsimilar drug delivery devices. For example, patients diagnosed with TypeI or II diabetes need to regularly check their blood glucose levels andself-administer an appropriate dose of insulin using an injection pen.In order to monitor the efficacy of the medication, dose informationmust be recorded. The process of manually logging dose information,particularly in an uncontrolled setting, is tedious and error prone.Patients often forget to log the dose information when administeringmedicine. In addition, many such patients may be minors or elderly whocannot efficiently and/or accurately track the dose information.

Incomplete dosage records hinder the ability of the patient toself-manage disease conditions and prevent caretakers from adjustingcare plans through behavioral insights. Lack of adherence to targetdosage schedules for injectable medicine may result in an increased needfor critical care, which results in a significant increase in healthcare costs in countries around the world.

Thus, a need exists for better technological aids to assist patients inimproving their ability to self-manage disease treatment. Such aids notonly improve patient awareness and education about their health, butalso assist caregivers in better monitoring patient health. Inparticular, there is a need for systems, devices, and methods thatfacilitate data acquisition on patient behavior and that allow that datato be used to reduce the incidence of hospital visits (e.g.,re-admission), as well as to inform and educate patients, careproviders, family and financial service providers.

SUMMARY

An apparatus for measuring liquid volume in a container includes a lightsource disposed and configured to emit electromagnetic radiation, alight guide disposed and configured to receive at least a portion of theemitted electromagnetic radiation, the light guide distributing at leasta portion of the received electromagnetic radiation over a length of thelight guide and directing the distributed electromagnetic radiationtoward the container, a plurality of sensors optically coupleable to thelight guide, each sensor of the plurality of sensors disposed andconfigured to detect at least a portion of the distributedelectromagnetic radiation, and a processing unit configured to receivedata representative of at least the portion of the detectedelectromagnetic radiation from each of the plurality of sensors, theprocessing unit operable to convert the received data into a signaturerepresentative of the electromagnetic radiation detected by theplurality of sensors.

It should be appreciated that all combinations of the foregoing conceptsand additional concepts discussed in greater detail below (provided suchconcepts are not mutually inconsistent) are contemplated as being partof the inventive subject matter disclosed herein. In particular, allcombinations of claimed subject matter appearing at the end of thisdisclosure are contemplated as being part of the inventive subjectmatter disclosed herein. It should also be appreciated that terminologyexplicitly employed herein that also may appear in any disclosureincorporated by reference should be accorded a meaning most consistentwith the particular concepts disclosed herein.

Other systems, processes, and features will become apparent to thoseskilled in the art upon examination of the following drawings anddetailed description. It is intended that all such additional systems,processes, and features be included within this description, be withinthe scope of the present invention, and be protected by the accompanyingclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

The skilled artisan will understand that the drawings primarily are forillustrative purposes and are not intended to limit the scope of theinventive subject matter described herein. The drawings are notnecessarily to scale; in some instances, various aspects of theinventive subject matter disclosed herein may be shown exaggerated orenlarged in the drawings to facilitate an understanding of differentfeatures. In the drawings, like reference characters generally refer tolike features (e.g., functionally similar and/or structurally similarelements).

FIG. 1 is a schematic block diagram of a dose measurement system inaccordance with some embodiments.

FIG. 2 is a perspective view of a dose measurement system in accordancewith some embodiments.

FIG. 3 is an exploded perspective view of the dose measurement system ofFIG. 2 in accordance with some embodiments.

FIG. 4 is an exploded top view of the dose measurement system of FIG. 2in accordance with some embodiments.

FIG. 5 is a schematic illustration of a communications interface, whichmay be included in the dose measurement system of FIG. 2 in accordancewith some embodiments.

FIG. 6 is a schematic ray diagram of different modes of lighttransmission between a first medium and a second medium in accordancewith some embodiments.

FIG. 7 is a cross-sectional view of a dose measurement system inaccordance with some embodiments.

FIG. 8 is a cross-sectional view of a dose measurement system inaccordance with some embodiments.

FIG. 9 is a cross-sectional view of a dose measurement system inaccordance with some embodiments.

FIG. 10 is a cross-sectional side view of a dose measurement system inaccordance with some embodiments.

FIGS. 11A-11C are cross-sectional views of a dose measurement system, ina first, second and third configuration, respectively, in accordancewith some embodiments.

FIG. 12 is a cross-sectional view of the dose measurement system of FIG.11A taken along line A-A, in accordance with some embodiments.

FIG. 13 is a cross-sectional view of the dose measurement system of FIG.11C taken along line B-B, in accordance with some embodiments.

FIG. 14 is a graph showing reference signature signals of sensors of adose measurement system in accordance with some embodiments.

FIG. 15 is a flow diagram of a method of operation of the dosemeasurement system in accordance with some embodiments.

FIG. 16 is a flow diagram of a method of operation of the dosemeasurement system in accordance with some embodiments.

FIG. 17 is a schematic block diagram of a health management systemassociated with a dose measurement system in accordance with someembodiments.

FIG. 18 is a perspective view of a dose measurement system in accordancewith some embodiments.

FIG. 19 is an exploded perspective view of the dose measurement systemof FIG. 18 in accordance with some embodiments.

FIG. 20 is an exploded top view of the dose measurement system of FIG.18 in accordance with some embodiments.

FIG. 21 is a perspective view of a light guide of the dose measurementsystem of FIG. 18 in accordance with some embodiments.

FIG. 22 is a schematic side view of the light guide of FIG. 18 inaccordance with some embodiments.

FIG. 23 is a cross-sectional perspective view of the dose measurementsystem of FIG. 18 in accordance with some embodiments.

FIG. 24 is a cross-sectional side view of the dose measurement system ofFIG. 18 in accordance with some embodiments.

FIG. 25A is a cross-sectional schematic illustration of a dosemeasurement system in accordance with some embodiments.

FIG. 25B is a cross-sectional schematic illustration of a dosemeasurement system in accordance with some embodiments.

FIGS. 26A-26C are cross-sectional schematic illustrations of a dosemeasurement system, in a first, second, and third configuration,respectively, in accordance with some embodiments.

FIG. 27 is an exploded perspective view of a drug delivery device with adose measurement system in accordance with some embodiments.

FIG. 28 is a schematic illustration of a dose measurement system, inaccordance with some embodiments.

DETAILED DESCRIPTION

Embodiments described herein relate generally to devices, systems andmethods for measuring a quantity of a liquid disposed in a container,and in particular to a volume or number of doses remaining in a drugdelivery device. In some embodiments, a dose measurement system formeasuring the liquid volume in a container includes a light sourceand/or light guide disposed and configured to emit/distributeelectromagnetic radiation toward the container. A plurality of sensorsare optically coupleable to the light source and are disposed andconfigured to detect at least a portion of the electromagnetic radiationemitted/distributed by the light source and/or light guide. Theapparatus also includes a processing unit configured to receive datarepresenting the portion of the detected electromagnetic radiation fromeach of the plurality of sensors and to convert the received data into asignature representative of the electromagnetic radiation detected bythe plurality of sensors.

In some embodiments, a method of estimating a volume of liquid in a drugdelivery device includes causing a light source and/or light guide toemit/distribute electromagnetic radiation toward a drug container anddetecting a signature of the emitted/distributed electromagneticradiation through the drug container with a plurality of sensors. Thedetected signature is then compared to a plurality of referencesignatures to determine the volume of liquid in the drug container. Eachof the plurality of reference signatures correspond to a volume levelremaining in the drug container. In some embodiments, detecting thesignature of the emitted/distributed electromagnetic radiation throughthe drug container includes detecting at least a portion of theelectromagnetic radiation emitted/distributed from the light sourceand/or light guide. The portion of the electromagnetic radiationdetected by each of the plurality of sensor devices may be compiled intothe signal signature.

In some embodiments, the method also includes calculating a dosedelivered to a patient based on the volume of liquid in the drugcontainer. In some embodiments, the dose delivered to a patient iscompared with a patient medication schedule to monitor compliance. Themethod may further include correcting the signal signature forbackground light which can contribute to noise. The correction mayinclude comparing the signal signature with a background signaturedetected by the plurality of sensors in a dark state of the lightsource. In some embodiments, the method also includes generating theplurality of reference signatures by recording the signature for a rangeof dose volumes in the drug container. The method also may includeassociating the signal with the reference signature using probabilisticmatching to determine the volume of liquid remaining in the dosecontainer.

In some embodiments, a method for determining a dose delivered by aninjection pen using the drug measurement system includes causing a lightsource and/or light guide to emit/distribute electromagnetic radiationtoward the injection pen a first time and detecting a first signature ofthe emitted/distributed electromagnetic radiation through the injectionpen with a plurality of sensors. The first signature is then compared toa plurality of reference signatures to determine the first volume ofliquid in the injection pen. The method further includes causing thelight source and/or light guide to emit/distribute electromagneticradiation toward the injection pen a second time, after the first time,and detecting a second signature of the emitted/distributedelectromagnetic radiation through the injection pen with the pluralityof sensors. The second signature is then compared to the plurality ofreference signatures to determine the second volume of liquid in theinjection pen. The second volume may be deducted from the first volumeto determine a dose delivered from the injection pen.

In some embodiments, the light source and the plurality of sensors aredisposed in an injection pen cap. In some embodiments, the methodincludes detecting the first signature prior to the injection pen capbeing removed from the injection pen and detecting the second signatureafter the injection pen cap has been placed back on the injection pen.The method also may include communicating the dose delivered informationto an external device. In some embodiments, the method includesswitching the pen cap to a power save mode after a predetermined periodof inactivity of the pen cap and/or based on available power (e.g.,battery level). In some embodiments, the method further includesalerting the user if a volume of liquid remaining in the drug containeris critically low, if it is time to deliver a dose of medication, ifavailable power drops below a predetermined level, if an unexpected orincorrect medication is being used, and/or if a medication is beingdelivered at an unexpected or incorrect time.

In some embodiments, a health management system includes a drug deliverydevice including a drug reservoir, and a dose measurement systemconfigured to be removably coupleable to the drug delivery device. Thedose measurement system includes a light source and/or light guidedisposed and configured to emit/distribute electromagnetic radiationtoward the drug reservoir a plurality of sensors optically coupleable tothe light source disposed and configured to detect a quantity ofelectromagnetic radiation communicated through the drug reservoir. Thequantity of electromagnetic radiation serves as a signaturerepresentative of the volume of liquid remaining in the drug reservoir.The health management system also includes a display configured topresent information to a user indicative of the volume of liquidremaining in the drug reservoir. The dose measurement system may beconfigured to communicate data representative of the volume of liquidremaining in the drug reservoir to a remote device, for example, toallow the remote device to calculate a dose delivered to the patient. Insome embodiments, the dose management system is configured to receiveuser health data from the remote device which may include, for exampleuser blood glucose level, user diet, user exercise, and/or user homehealth monitored data.

In some embodiments, a light source includes a single light source(e.g., a single LED) paired with a light guide. The light source isdisposed and configured to emit electromagnetic radiation into the lightguide. The light guide is disposed and configured to receive the emittedelectromagnetic radiation. The light guide may be a light pipe or lighttube for transporting, redirecting, and/or otherwise distributing thereceived electromagnetic radiation toward the container.

In some embodiments, the light guide comprises a hollow structure withreflective and/or absorptive inner walls for controlling leakage ofand/or containing at least some of the electromagnetic radiation (e.g.,a prism light guide or a molded plastic light tube). The inner walls maybe lined and/or treated with a reflective material and/or absorbingmaterial, such as Laser Gold® reflective plating and/or Laser Black™selectively absorbing coating (both available from Epner Technology,Inc. (Brooklyn, N.Y.)). A light guide may be designed to distributeelectromagnetic radiation over its length by defining, for example, oneor more openings or areas configured to allow at least someelectromagnetic radiation to be transmitted out of the light guide. Theopenings or areas may be disposed for directing electromagneticradiation toward different points along a container. The openings orareas function as a pseudo-plurality of light sources.

In some embodiments, a light guide comprises a transparent solidstructure for controlling leakage of and/or containing at least some ofthe electromagnetic radiation by internal reflection (e.g., an opticalfiber). A light guide may be designed to transmit at least some of theelectromagnetic radiation toward different points along a container. Thedistribution of the transmitted electromagnetic radiation may be uniformor nearly uniform (e.g., using microscopic prisms) over the length ofthe light guide, thereby functioning as a pseudo-plurality of lightsources.

The geometry and dimensions of a light guide may vary from other lightguides or between components of the light guide itself. For example, across-section of at least a portion of a light guide may be round,square, hexagonal, etc. A light guide may not be straight, but instead,may have one or more bends and/or angles. In some embodiments, a lightguide includes a dome or cupola for collecting and reflecting as muchelectromagnetic radiation as possible into the light guide. A lightguide also may have directional collector devices, reflector devices,and/or lens devices (e.g., a Fresnel lens device) to assist incollecting additional directional electromagnetic radiation. In someembodiments, a light guide includes one or more diffusers to spread thelight toward a container.

According to some embodiments, a plurality of sensors are opticallycoupleable to the light guide and are disposed and configured to detectthe electromagnetic radiation distributed by at least a portion of thelight guide (e.g., directed through at least one opening or area ordistributed over some length of the light guide). A processing unit maybe configured to receive data representing the portion of the detectedelectromagnetic radiation from each of the plurality of sensors and toconvert the received data into a signature representative of theelectromagnetic radiation detected by the plurality of sensors.

As used in this specification, the terms “about” and “approximately”generally include plus or minus 10% of the value stated. For example,about 5 would include 4.5 to 5.5, approximately 10 would include 9 to11, and about 100 would include 90 to 110.

FIG. 1 is a schematic block diagram of a dose measurement system 100 formeasuring the dose in a drug delivery device 110. The dose measurementsystem 100 includes a lighting module 140, a sensing module 150, aprocessing unit 160 and a communications module 170. The dosemeasurement system 100 may be configured to be removably coupleable tothe drug delivery device 110 that is used to deliver a drug dose to atarget T such as, for example, a human patient.

The drug delivery device 110 may be any drug delivery device 110 thatcan be used for injecting a medication into a patient. For example, thedrug delivery device 110 may be an injection device or pen (e.g.,insulin injection pen), a syringe, an infusion device or pump (e.g.,insulin delivery pump), an ampoule, or a vial. The dose measurementsystem 100 may be configured to be coupleable to a wide variety of drugdelivery devices 110, using, for example, different shapes, sizes, anddrug volumes. In some embodiments, the dose measurement system 100 isconfigured to receive a portion of the drug delivery device 110 (e.g., aportion that defines an internal volume containing the drug, aninjector, and/or plunger). In some embodiments, the dose measurementsystem 100 is configured to be removable from the drug delivery device110 when the user is delivering a dose to the target T. In someembodiments, the dose measurement system 110 can remain attached to thedrug delivery device 110 when the user is delivering a dose to thetarget T. In some embodiments, the dose measurement system 100 isconfigured to be reusable. In some embodiments, the dose measurementsystem 110 is permanently coupled to the drug delivery device 110, forexample, integrated into the body of the drug delivery device. In suchembodiments, the dose measurement system 100 may be disposable.

The lighting module 140 may include a light source and/or light guideconfigured to emit/distribute electromagnetic radiation toward the drugdelivery device 110. In some embodiments, the light source and/or lightguide is configured to emit/distribute electromagnetic radiation towarda drug reservoir (not shown) of the drug delivery device 110. In someembodiments, the light source is a light emitting diode (LED). In someembodiments, the light source is configured to emit infrared radiationor microwave radiation, such that the electromagnetic radiation canpenetrate through a housing and/or any internal components of the drugdelivery device 110, and/or the liquid drug contained therein. In someembodiments, the light source is configured to emit continuouselectromagnetic radiation for a predefined time period. In someembodiments, the light source is configured to emit pulses ofelectromagnetic radiation (e.g., a series of less than 100 microsecondpulses or pulses about 200 microseconds apart plus or minus 100microseconds).

The lighting module 140 may include a light source and a light guide.The light source may be configured to emit electromagnetic radiationtoward and into the light guide. The light guide may be configured toreceive and reflect the electromagnetic radiation emitted by the lightsource toward the drug delivery device 110. In some embodiments, thelight guide is configured to output electromagnetic radiation toward adrug reservoir (not shown) of the drug delivery device 110. In someembodiments, the light source is a single LED. In some embodiments, thelight source is configured to emit infrared radiation or microwaveradiation, such that the electromagnetic radiation can travel throughthe light guide and penetrate through a housing and any internalcomponents of the drug delivery device 110, and/or the liquid drugcontained therein. In some embodiments, the light source is configuredto emit continuous electromagnetic radiation for a predefined timeperiod. In some embodiments, the light source is configured to emitpulses of electromagnetic radiation (e.g., a series of less than 100microsecond pulses or pulses about 200 microseconds apart plus or minus100 microseconds).

The sensing module 150 includes a plurality of sensors that areoptically coupleable to the light source, the light guide, or acombination thereof. In some embodiments, each of the plurality ofsensors may be a photodetector. The plurality of sensors are disposedand configured to detect at least a portion of the electromagneticradiation emitted/distributed by the light source and/or the lightguide. In some embodiments, the detected electromagnetic radiationincludes transmitted, refracted, and/or reflected portions of theelectromagnetic radiation. In some embodiments, the refractedelectromagnetic radiation includes multi-directional refraction causedby a lensing effect of a curved surface of the housing of the drugdelivery device 110 and/or the drug reservoir.

The processing unit 160 is configured to receive the electromagneticradiation signal from the sensing module 150 (i.e., each of theplurality of sensors) and convert the received data into a signalsignature representative of the electromagnetic radiation detected byeach of the plurality of sensors. The processing unit 160 may include aprocessor, such as a microcontroller, a microprocessor, an ASIC chip, anARM chip, an analog to digital convertor (ADC), and/or a programmablelogic controller (PLC). In some embodiments, the processing unit 160includes a memory that is configured to temporarily store at least oneof the electromagnetic radiation data detected by each of the pluralityof sensors and the signal signature produced from it. In someembodiments, the memory also is configured to store a plurality ofreference signatures. Each of the plurality of reference signatures maybe representative of a drug volume in the drug delivery device 110. Insome embodiments, the processing unit 160 also includes an RFID chipconfigured to store information (e.g., remaining volume or doseinformation) and to allow a near field communication (NFC) device toread the stored information. In some embodiments, the processing unit160 is configured to associate the signal signature with the referencesignature to determine a volume or number of doses remaining in and/orinjected by the drug delivery device 110. In some embodiments, theprocessing unit 160 can also be configured to determine the type of drugdelivery device 110 coupled to the dose measurement system 100, and/orthe drug contained in the drug delivery device 110. In some embodiments,the processing unit 160 also includes a global positioning system (GPS)to, for example, determine a current location of the dose measurementsystem 100.

The communications module 170 may be configured to allow two-waycommunication with an external device (e.g., a smart phone, a localcomputer, and/or a remote server). In some embodiments, thecommunications module 170 includes a communication interface to providewired communication with the external device (via, e.g., a USB orfirewire interface). In some embodiments, the communication interfacealso is used to recharge a power source (not shown), such as arechargeable battery. In some embodiments, the communications module 170includes means for wireless communication with the external device(e.g., Wi-Fi, Bluetooth® wireless technology, Bluetooth® low energytechnology, Zigbee and the like).

In some embodiments, the communications module 170 includes a displayconfigured to communicate a status of the dose measurement system 100 tothe user, including but not limited to a volume or number of dosesremaining, history of use, remaining battery life, wireless connectivitystatus, and/or user reminders. In some embodiments, the status alsoincludes information on whether an injector, for example, a needle, isattached/detached to the drug delivery device 110. Generally a user isrequired to attach a new injector (e.g., needle) to the drug deliverydevice 110 prior to each drug injection. Status information on theinjector attachment/detachment can therefore inform the user and/or anexternal monitor (e.g., a doctor) whether the user is replacing theinjector after each injection.

In some embodiments, the communications module 170 also includesmicrophones and/or vibration mechanisms to convey audio and tactilealerts. In some embodiments, the communications module 170 includes auser input interface (e.g., a button, a switch, an alphanumeric keypad,and/or a touch screen) to allow a user to, for example, inputinformation into the dose measurement system 100, power ON the system,power OFF the system, reset the system, manually input details of apatient behavior, manually input details of drug delivery device 110usage, and/or manually initiate communication between the dosemeasurement system 100 and a remote device.

The dose measurement system 100 may be disposed in a housing (not shown)that can be configured to be removably coupleable to the drug deliverydevice 110. For example, the lighting module 140, sensing module 150,processing unit 160, and/or the communications module 170 may beincorporated into a housing. One or more individual components of thedose measurement system 100 (e.g., the lighting module 140 and thesensing module 150) may be incorporated into a first housing while oneor more other components (e.g., the processing unit 160 andcommunications module 170) may be separate and/or incorporated into asecond housing. In some embodiments, the housing is configured (e.g.,shaped and sized) to be removably coupled to at least a portion of thedrug delivery device 110. For example, the housing may have a recessand/or define a bore into which a portion of the drug delivery device110 can be received. The housing may have alignment features to allowthe dose measurement system 100 to be coupled to the drug deliverydevice 110 in a predetermined radial orientation. The housing may beopaque and include an insulation structure to prevent interference fromambient electromagnetic radiation (e.g., to increase signal quality).For example, the insulation structure may be a metal lining configuredto shield the electronic components of the dose measurement system 100from external electromagnetic radiation. In some embodiments, thehousing can substantially resemble a cap to act as a replacement cap forthe drug delivery device 110 (e.g., a pen cap for an injection pen). Insome embodiments, the insulating structure may include plastic mixedwith a metallic compound (e.g., titanium dioxide) to modify a propertyof the insulation structure. For example, the addition of certainmetallic compound can modify the light transmissivity of the housing(e.g., to make it more opaque). In some embodiments, the addition oftitanium dioxide to plastic can be used to modify the coloring (e.g.,improve the whiteness) of the housing. In some embodiments, an averageof 3%-5% by volume of titanium dioxide can be added to thermosetting andthermoplastic materials (e.g., polyolefins, polystyrene, ABS, polyvinylchloride, a combination thereof, and/or the like) to form the insulatingstructure. In some embodiments, the insulating structure can shield theelectronic components of the dose measurement system 100 from externalelectromagnetic radiation. In some embodiments, the opaque nature of theinsulating structure due to addition of an opacifier such as titaniumdioxide, may prevent external infrared radiation from entering thehousing. In this manner, the insulating structure may shield theelectronic components of the dose measurement system 100 from externalelectromagnetic radiation. In some embodiments, the insulating structuremay prevent the infrared radiation emitted by the lighting module 140from passing through the walls of the housing and/or the pen cap. Thatis, electromagnetic radiation emitted by the lighting module 140 can beprevented from leaving the housing and/or the pen cap. This preventselectromagnetic radiation emitted by the lighting module 140 fromleaving the housing, bouncing back off an external object (e.g., table,chair, cell phone, etc.) and then returning back into the housing and/orpen cap. In this manner, in addition to canceling ambient light theinsulating structure may correct electromagnetic and/or infraredradiation that may be reflected back into the housing and/or pen cap.

In some embodiments, the lighting module 140 and the sensing module 150are disposed and oriented in the housing of the dose measurement system100, such that the light source and/or the light guide is disposed on afirst side, and the plurality of sensors are disposed on a second sideof the drug delivery device 110. In some embodiments, the light sourceand/or the light guide is disposed at a first radial position withrespect to the drug delivery device 110, and the plurality of sensorsare disposed at a second radial position which is different than thefirst radial position (e.g., the second radial position is approximately180 degrees from the first radial position). In other words, the dosemanagement system 100 may be arranged so that the light source and/orthe light guide is disposed on one side of a drug reservoir, and theplurality of sensors are disposed on the opposite side of the drugreservoir. In some embodiments, the plurality of sensors are disposed ina substantially straight line. In some embodiments, the plurality ofsensors are disposed in a substantially straight line that issubstantially parallel to the elongate axis of the light guide. In someembodiments, the light guide is disposed such that the distribution ofelectromagnetic radiation is parallel to and in line of sight of atleast one sensor. In other embodiments, the light guide is disposed suchthat each opening or area for transmitting electromagnetic radiation islocated adjacent to at least one sensor, each opening or area also beinglocated parallel to and in line of sight of at least one sensor. In someembodiments, at least one of the light guide distribution, openings, orareas and/or at least one of the plurality of sensors is located in aninclined orientation with respect to a longitudinal axis of the drugdelivery device 110. In some embodiments, the number of the plurality ofsensors is equal to, greater than, or less than a number of light guideopenings or areas for transmitting electromagnetic radiation. In someembodiments, the light guide can be disposed along a light guide axis ona second side of the drug reservoir such that the light guide axis issubstantially parallel to the longitudinal axis of the dose measurementsystem 100. In some embodiments, the plurality of sensors can bedisposed along a sensor axis on a first side of the drug reservoir suchthat the sensor axis is substantially parallel to the longitudinal axisof the dose measurement system 100. In some embodiments, the lightsource can be disposed and configured to emit electromagnetic radiationalong the light guide axis. In some embodiment, the light source can beangled downwards and is not facing the first side of the drug reservoir.That is, the light source is angled in such a manner that the lightsource is approximately perpendicular to the plurality of sensors. Insome embodiments, the dose measurement system 100 can include at leastone opening or area on the second side of the drug reservoir todistribute at least a portion of the electromagnetic radiation emittedby the light source. In some embodiments, the dose measurement system100 can include a light guide on the second side of the drug reservoirto distribute at least a portion of the electromagnetic radiationemitted by the light source. In some embodiments, the light guide isdisposed such that the elongated axis of the light guide issubstantially parallel to the plurality of sensors. Scattered portionsof the electromagnetic radiation emitted from the light guide may bedetected by the plurality of sensors.

In some embodiments, the light source and/or the light guide and theplurality of sensors are configured such that the dose measurementsystem 110 can detect the volume of drug in the drug delivery device 110with a resolution of 1 unit of drug or smaller (e.g., fractions of unitsof drug such as 0.1 units, 0.2 units, 0.5 unites, etc.). In someembodiments, the light source and/or light guide and the plurality ofsensors are configured such that the dose measurement system 110 candetect the position of a plunger portion of an actuator disposed in thedrug delivery device 110 with a resolution of about 10 micrometers,about 20 micrometers, about 30 micrometers, about 40 micrometers, about50 micrometers, about 60 micrometers, about 70 micrometers, about 80micrometers, about 90 micrometers, about 100 micrometers, about 110micrometers, about 120 micrometers, about 130 micrometers, about 140micrometers, about 150 micrometers, about 160 micrometers, about 170micrometers, about 180 micrometers, or about 200 micrometers, inclusiveof all ranges therebetween.

Having described above various general principles, several exemplaryembodiments of these concepts are now described. These embodiments areonly examples, and many other configurations of a dose measurementsystem, systems and/or methods for measuring dose delivered by a drugdelivery device and overall health of a patient are envisioned.

Referring now to FIGS. 2-4 a dose measurement system 200 may include alighting module 240, a sensing module 250, a processing unit 260, acommunications module 270, and a power source 286. The dose measurementsystem 200 may be configured to be removably coupleable to a drugdelivery device 210 (also referred to herein as “an injection pen 210”).The drug delivery device 210 may be configured to deliver a predefinedquantity of a drug (e.g., a dose) to a patient. Examples of the drugdelivery device 210 include insulin injection pens that can be used by apatient to self-administer insulin. As described herein, the drugdelivery device 210 may include a housing 212, an actuator 214, and aninjector 216. The housing 212 may be relatively opaque, such that itonly allows select wavelengths of electromagnetic radiation to betransmitted therethrough (e.g., infrared or microwave radiation). Thehousing 210 defines an internal volume (e.g., a reservoir) for storing adrug. The actuator 214 may include a plunger portion in fluidcommunication with the drug and configured to communicate a predefinedquantity of drug to the patient. The actuator 214 may be configurable(e.g., by the user) to dispense variable quantities of the drug. Theinjector 216 may be configured to penetrate a user's skin forintramuscular, subcutaneous, and/or intravenous delivery of the drug.

The dose measurement system 200 includes a housing 220 that includes atop housing portion 222 (also referred to herein as “top housing 222”)and a bottom housing portion 224 (also referred to herein as “bottomhousing 224”). The top housing portion 222 and the bottom housingportion 224 may be removably or fixedly coupled together by, forexample, gluing, hot welding, a snap-fit mechanism, screws, or by anyother suitable coupling means. The housing 220 may be made from a rigid,light weight, and opaque material including, but not limited to,polytetrafluoroethylene, high density polyethylene, polycarbonate, otherplastics, acrylic, sheet metal, any other suitable material, or acombination thereof. The housing 220 may be configured to shield theinternal electronic components of the dose measurement system 200 fromenvironmental electromagnetic noise. For example, the housing mayinclude an insulation structure (not shown) such as, for example,aluminum lining or any other metal sheet or foil that can serve as anelectromagnetic shield.

As shown in FIG. 3, the top housing portion 222 defines an internalvolume for substantially housing the lighting module 240, the sensingmodule 250, the processing unit 260, the communications module 270, andthe power source 286. The bottom housing portion 224 defines a bore 226,shaped and sized to receive at least a portion of the drug deliverydevice 210. For example, the bore 226 may be shaped and sized to receiveonly the drug containing portion of the housing 212 and the injector216. The bore 226 may be configured to receive the drug delivery device210 in a preferred orientation (e.g., a preferred radial orientation).In some embodiments, the bore 226 is in close tolerance with thediameter of the drug delivery device 210, for example, to form afriction fit with the drug delivery device 210. In some embodiments, thebore 226 includes one or more notches, grooves, detents, any othersnap-fit mechanism, and/or threads, for removably coupling the drugdelivery device 210 to the bottom housing 224. In some embodiments,bottom housing portion 224 includes one or more alignment features toallow the drug delivery device 210 to be coupleable with the dosemeasurement system 200 in a predetermined radial orientation.

In some embodiments, the bottom housing 224 includes one or moreapertures 228 for receiving at least a portion of the light sourceand/or light guide 244 of the lighting module 240, and/or sensors 254 ofthe sensing module 250. The apertures 228 may be configured to providemechanical support for the light source and/or light guide 244 and/orsensors 254, or can serve as an alignment mechanism for the lightingmodule 240 and/or sensing module 250.

As shown in FIG. 4, the top housing 222 includes an opening 230 forreceiving at least a portion of the communications module 270 such as,for example, a communication interface to provide wired communicationwith an external device, and/or an interface for charging the powersource 286. In some embodiments, the top housing 222 also includesfeatures (e.g., recesses, apertures, cavities, etc.) for receiving aportion of the drug delivery device 210 such as the injector 216. Insome embodiments, the housing 220 also includes a detection mechanism(not shown) to detect if the drug delivery device 210 has been coupledto the dose measurement system 200 (e.g., a push switch, a motionsensor, a position sensor, an optical sensor, a piezoelectric sensor, animpedance sensor, or any other suitable sensor). The housing 220 may berelatively smooth and free of sharp edges. In some embodiments, thehousing 220 is shaped to resemble a pen cap that has a form factor thatoccupies minimal space (e.g., fits in the pocket of a user). In someembodiments, the housing 220 also includes features for handling (e.g.,clips for attaching to a user's shirt pocket) and/or various ornamentalfeatures. In some embodiment, the dose measurement system 200 alsoserves as a replacement cap for the drug delivery device 210. In someembodiments, the housing 220 also includes one or more sensors (e.g.,optical sensors) to determine a status of the drug delivery device 210,for example, if the injector 216 (e.g., a needle) is attached/detachedto the drug delivery device 210.

Referring still to FIGS. 3 and 4, the light source and/or light guide244 (e.g., an LED) of the lighting module 240 is mounted on, orotherwise disposed on, a printed circuit board (PCB) 242. The PCB 242may be any standard PCB made by any commonly known process. In someembodiments, the light source and/or light guide 244 is arranged toemit/distribute electromagnetic radiation along the length of thehousing such that, when the portion of the drug delivery device 210 thatdefines the internal volume of the housing 212 holding the drug iscoupled with the dose measurement system 200, the light source and/orlight guide 244 can illuminate the entire internal volume. In someembodiments, the light source and/or light guide 244 is fabricated andoriented in another shape or configuration, such that theelectromagnetic radiation is distributed unequally, alternately with thesensors 254, in a zig-zag pattern, or using any other configuration asdescribed herein.

In some embodiments, the light sources and/or light guide 244 isconfigured to produce an electromagnetic radiation of a wavelength thatis capable of penetrating through the housing 212 of the drug deliverydevice 210, the drug contained therein, and/or a portion of the housing220. For example, infrared radiation or microwave radiation canpenetrate many of the plastic materials that are commonly used inmanufacturing drug delivery devices (e.g., injection pens). In someembodiments, an electromagnetic radiation has a frequency that also canpenetrate through the internal components of the drug delivery device210, such as the plunger portion of the actuator 214. In someembodiments, the light source and/or light guide is 244 configured toproduce a wide beam of electromagnetic radiation (e.g., a wide-angledLED or a diffused exit opening of a light guide). Said another way, theelectromagnetic radiation cone of a single light source and/or openingin a light guide 244 may have a wide angle, and the electromagneticradiation cones of adjacent openings in a light guide 244 may overlap.In some embodiments, a light source and/or light guide 244 is configuredto emit/distribute pulses of electromagnetic radiation (e.g., a seriesof less than 100 microsecond pulses or pulses about 200 microsecondsapart plus or minus 100 microseconds).

The plurality of sensors 254 of the sensing module 250 may be mountedon, or otherwise disposed on, a PCB 252. The PCB 252 may be any standardPCB made by any commonly known process. The plurality of sensors 254 maybe any optical sensors (e.g., photodiodes) optically coupleable with thelight source and/or light guide 244 and configured to detect at least aportion of the electromagnetic radiation emitted/distributed by thelight source and/or light guide 244. The electromagnetic radiation maybe transmitted radiation, refracted radiation (e.g., refracted throughair, drug, and/or body of drug delivery device 210), reflected radiation(e.g., reflected from a wall of the housing 220 or internally reflectedfrom a wall of the drug delivery device 210), and/or multi-directionalrefraction/reflection caused by a lensing effect of a curved surface ofthe housing 212 and/or the drug reservoir. The transmitted, refracted,and/or reflected electromagnetic signal received by the plurality ofsensors 254 may be used to create a signal signature (e.g., by theprocessing unit 260). The signal signature may then be associated with areference signature to determine the volume or number of doses remainingin the drug delivery device 210. In some embodiments, the signalresponse of the sensors may be used to measure usability metrics suchas, for example, determining the presence of the injector 216 of thedrug delivery device 210, and/or determining whether the drug deliverydevice 210 is coupled or uncoupled to the dose measurement system 200.In some embodiments, the signal response of the sensors 254 also may beused to determine the type of a drug delivery device 210 is coupled tothe dose measurement system 200, and/or the type of drug present in thedrug delivery device 210.

In some embodiments, the sensors 254 are arranged in a substantiallysimilar configuration to the light source and/or light guide 244. Insome embodiments, the number of sensors 254 is the same as, greaterthan, or less than the number of pseudo-light sources created by thelight source and light guide 244. In some embodiments, the light sourceand/or light guide 244 and/or sensors 254 are arranged in an inclinedorientation.

The processing unit 260 may include a PCB 262 and a processor 264. ThePCB 262 may be any standard PCB made by any commonly known process andmay include amplifiers, transistors and/or any other electroniccircuitry as necessary. The processor 264 may be any processor,including, but not limited to, a microprocessor, a microcontroller, aPLC, an ASIC chip, an ARM chip, an ADC, and/or any other suitableprocessor. The processing unit 260 may be coupled to the lighting module240 and the sensing module 250 using electronic couplings 266, such thatthe lighting module 240 and the sensing module 250 are orientedperpendicular to the processing unit 260 and parallel to each other. Insome embodiments, the processing unit 260 includes an onboard memory forat least temporarily storing a signal signature, a reference signaturedatabase, dose information, user health data (e.g., blood glucoselevel), device location data (e.g., from a GPS optionally included inthe dose measurement system 200 or from another GPS enabled device thatis paired with the system 200 such as a blood glucose meter or cellularphone), and/or any other data as might be useful for a patient to managetheir health. In some embodiments, the processing unit 260 includes anRFID chip configured to store information and/or allow an NFC device toread the information stored therein. The processing unit 260 may beconfigurable to control the operation of the dose measurement system200, for example, activation and timing of the light source and/or lightguide 244, and/or reading and processing of electromagnetic radiationdata from the sensors 254. For example, the processing unit 260 may beconfigured to compare electromagnetic radiation signal signatureobtained from the plurality of sensors 254 and associate it with thereference signature database to determine the volume or quantity ofdoses remaining in the drug delivery device 210 or the position of theactuator 214 (e.g., plunger) of the drug delivery device 210.

In some embodiments, the processing unit 260 is configured to correctthe signal signature for background noise. For example, the processingunit 260 may be configured to operate the sensing module 250 to detect abackground signature with the lighting module in dark state, i.e., thelight source 244 switched off. The background signature can then beassociated with the signal signature to correct for background noise. Insome embodiments, the processing unit 260 also includes electronicsignal filtering algorithms, including, but not limited to, Fouriertransforms, low pass filter, band filter, high pass filter, Besselfilter, and/or any other digital filter to reduce noise and increasesignal quality. The processing unit also may be configured to obtainreference signatures by storing the electromagnetic radiation signaldetected by the sensing module 250 for a range of dose volumes in arepresentative drug delivery device 210, including, but not limited to,electromagnetic radiation signal at drug delivery device 210 being full,being empty, and a series of intervals there between (e.g., every unitof dose dispensed from the drug delivery device and/or every 170micrometer displacement of a plunger portion of the actuator 214included in the drug delivery device 210).

In some embodiments, the processing unit 260 is configured to includeprobabilistic matching algorithms that can be used to associate thesignal signature with the reference signature to determine a volume ofliquid in the drug delivery device 210. In some embodiments, theprocessing unit 260 also includes algorithms to determine the type ofdrug delivery device 210 coupled to the dose measurement system 200and/or the drug contained within the drug delivery device 210, from thesignal signature. For example, drug delivery devices 210 of the sameform factor (i.e., size and shape) can include different drugs, forexample, insulin, epinephrine, or any other drug. In order to avoidconfusion, delivery device 210 manufacturers often provide marking,labeling, and/or color coding to distinguish between different drugs indelivery devices 210 that look similar. Said another way, once a drugdelivery device 210 company has designed and is manufacturing aparticular delivery device 210, they often use that same design fordifferent drug therapies. Therefore, in some embodiments, the algorithmsincluded in the processing unit 260 are configured to determine the typeof drug delivery device 210 coupled to the dose measurement system 200based on, for example, material properties (e.g., color, refractiveindex, etc.) of the device. For example, different materials and/orcolors can have different refractive indexes, which may be used foridentification. In some embodiments, the type of drug included in thedrug delivery device 210 also may be used to determine the type ofdelivery device 210 based on the refractive index of the drug.

The processing unit 260 also may be configured to control and operatethe communications module 270. In some embodiments, the processing unit260 is configured to operate the system in a power efficient manner. Forexample, the processing unit 260 may turn off the electronics poweringthe light source 244 (e.g., operational amplifiers) when they are notneeded. The processing unit 260 may pulse the LEDs for a short period athigh current to, for example, save power and/or increase signal to noiseratio. The processing unit 260 also may be configured to periodicallyactivate the communications module 270 (e.g., about 1-10 times per day)and/or when the dose measurement system 200 is attached to the drugdelivery device 210. Similarly, the processing unit 260 may turn thecommunications module 270 off when it is not needed. In someembodiments, the processing unit 260 also includes a global positioningsystem (GPS) to, for example, determine a current location of the dosemeasurement system 200.

The communications module 270 may be configured to communicate data tothe user and/or an external device, for example, a smart phoneapplication, a local computer, and/or a remote server. The communicateddata may include, but is not limited to, initial system activation,system ON/OFF, drug delivery device 210 coupled/uncoupled, injectorattached/detached from drug delivery device 210, volume remaining,number of doses remaining, dose history, time, system or drugtemperature, system location (GPS), drug delivery device 210coupling/uncoupling data, drug expiration date, velocity at which drugis delivered, device collisions, device power remaining, step count,tampering with the system, any other user health information, and/or anyother usable data. In some embodiments, the communications module 270 isconfigured to receive data, for example, new calibration data, firmwareupdates, user health information (e.g., blood glucose levels, diet,exercise, dose information) and/or any other information input by theuser, or communicated by an external device. The communications module270 may include conventional electronics for data communication and canuse a standard communication protocol, including, but not limited to,Wi-Fi, Bluetooth® wireless technology, Bluetooth® low energy technology,Zigbee, USB, firewire, and/or near field communication (e.g., infrared).In some embodiments, the communications module 270 is configured toperiodically connect (e.g., about 1-10 times per day) to the externaldevice (e.g., a smart phone) to log any dose data stored in the onboardmemory. In some embodiments, the communications module 270 is activatedon demand by the user.

Referring now also to FIG. 5, in some embodiments, the communicationsmodule 270 includes a communication interface 271 located on an externalsurface of the housing 210 of the dose measurement system 200 forcommunicating with the user. The communication interface 271 may includea switch 272 (e.g., a power switch, a reset button, and/or acommunication switch) to manually initiate communication with anexternal device (to activate, e.g., Bluetooth® wireless technology). Insome embodiments, the communications interface 271 also includes anindicator 274 such as a light source (e.g., an LED) to indicate to theuser, for example, if the dose measurement system 200 is ON/OFF, or thecommunication module 270 is active. In some embodiments, thecommunication interface 271 includes a display 276 for visualcommunication of information to the user, including, but not limited to,the volume or number of doses remaining 278 in the drug delivery device210, the current time 280, system power remaining 282, dose history 284(e.g., average dose usage, time last dose taken, etc.), an indication ofcharging status of the drug delivery device 210 (e.g., currentlycharging, fully charged, etc.), and/or wireless connectivity status. Insome embodiments, the communications interface 271 includes analphanumeric keypad, and/or a touch screen to, for example, allow a userto input information (e.g., food intake, exercise data, etc.) into thedose measurement system 200. In some embodiments, the communicationsmodule 270 includes a speaker for providing audible alerts or messagesto the user (e.g., dose reminders and reinforcement messages) and/or amicrophone for receiving audio input from the user. In some embodiments,the communications module 270 includes means for tactile alerts (e.g., avibration mechanism). In some embodiments, the communications module 270can communicate other information pertaining to user health, including,but not limited to, steps taken, calories burned, blood glucose levels,and/or any other information.

The power source 286 may be any power source that can be used to powerthe dose measurement system 200. In some embodiments, the power source286 includes an energy storage device (e.g., a disposable battery). Insome embodiments, the power source 286 includes a rechargeable battery,including, but not limited to, a NiCad battery, a Li-ion battery,Li-polymer battery, or any other battery that has a small form factor(e.g., of the type used in cell phones), and/or does not to be chargedfrequently (e.g., charged once per month). In some embodiments, thepower source 286 is charged using an external power source, including,but not limited to, though a power socket located on the housing 220and/or through a communication interface of the communications module270 (e.g., a USB interface). In some embodiments, the power source 286is charged using solar energy and may include solar panels. In someembodiments, the power source 286 is charged using kinetic energy andmay include mechanical energy transducers.

As described above, the plurality of sensors 254 of the sensing module250 are configured to receive at least one of a transmitted radiation,refracted radiation (e.g., refracted through air, the liquid drug, thehousing 212 of drug delivery device 210), reflected radiation (e.g.,reflected from a wall of the housing 220 or internally reflected from awall of the internal volume of the drug delivery device 210), andmulti-directional reflection/refraction (e.g., caused by a lensingeffect of a curved surface of the housing 212 of the drug deliverydevice 210). Referring now to FIG. 6, a light source L (e.g., a wideangle light source) can produce a plurality of light rays emanating anddiverging away from the light source. The light source L is present in afirst medium M1 (e.g., air) having a first refractive index n1. A secondmedium M2 (e.g., liquid drug) having a second refractive index n2,greater than the first refractive index (i.e., n2>n1), is bordered bythe first medium M1 on both sides. The second medium M2 also may includean opaque surface (e.g., a sidewall).

A first light ray L1 emitted by the light source L is incident on theinterface of the first medium M1 and the second medium M2 at a firstangle of 0 degrees. This light ray does not bend as it penetratesthrough the second medium M2 and transmits back into the first medium M1(the transmitted light) at the original angle of incidence. A secondlight ray L2 is incident on the interface of the first medium M1 and thesecond medium M2 at a second angle >0. The second light ray L2 bends orrefracts (the refracted light) as it penetrates the second medium M2,and then bends again to its original angle of incidence as it reentersthe first medium M1, parallel to but offset from the emitted ray L2. Athird light ray L3 is incident on the interface of the first medium M1and the second medium M2 at a third angle greater than the second angle.At this angle of incidence, the light ray L3 does not penetrate into thesecond medium M2, but it is reflected back into the first medium M1 (thereflected light), such that angle of reflection is equal to the angle ofincidence. A fourth light ray L4 is incident on the interface of thefirst medium M1 and the second medium M2 at a fourth angle less than thethird angle, such that the light ray L4 refracts in the second mediumM2, but is now incident on the opaque surface included in the secondmedium M2 (reflection from opaque surface). At least a portion of thelight ray L4 is reflected back into the second medium M2, which thenreenters back into the first medium M1 at a fifth angle, such that thefifth angle is not equal to the fourth angle.

As described herein, the electromagnetic radiation signal received bythe plurality of sensors 254 of the sensing module 250 may include acombination of the transmitted, refracted and reflected portions of theelectromagnetic radiation. A unique signal signature is produced by thecombination of the portions of the electromagnetic radiation atdifferent dose volumes remaining, and/or the actuator 216 position ofthe drug delivery device 210. This signal signature may be compared witha reference signal signature database (also referred to herein as “acalibration curve”) to obtain the volume or number of doses remaining indrug delivery device 210, as described in further detail herein.

Referring now to FIGS. 7-10, various configurations of the light sourceand/or light guide and the sensors are shown and described. While thetransmitted and reflected portion of the electromagnetic radiation isshown, the refractive portion is not shown for clarity. As shown in FIG.7, a dose measurement system 300 includes a plurality orpseudo-plurality (using a light guide) of light sources 344 and aplurality of sensors 354. A drug delivery device 310 is coupled to thedose measurement system 300. The drug delivery device 310 includes ahousing 312 and an actuator 314 that collectively define an internalvolume (e.g., a reservoir) for containing a drug. The drug deliverydevice 310 also includes an injector 316 for communicating the drug to apatient. The dose measurement system 300 is configured such that theplurality or pseudo-plurality of light sources 344 are disposed on afirst side of the housing oriented toward the drug delivery device 310and the plurality of sensors 354 are disposed on a second side of thehousing such that each of the plurality of sensors 354 is substantiallyopposite to, and in optical communication with, at least one of theplurality or pseudo-plurality of light sources 344. In some embodiments,the plurality or pseudo-plurality of light sources 344 and/or theplurality of sensors 354 are disposed in a substantially linearrelationship (e.g., a straight line) with respect to each other. Each ofthe plurality of sensors 354 receive a combination of transmitted,refracted and reflected electromagnetic radiation emitted/distributed bythe plurality or pseudo-plurality of light sources 344. The reflectionportion of the electromagnetic radiation may be reflected from a plungerportion of the actuator 314, and/or reflected from a housing of the dosemeasurement system 300 or the housing 312 of the drug delivery device310. The refraction may be from the housing 312 and/or from the liquiddrug disposed in the drug delivery device 310. The combination of thetransmitted, reflected, and refracted portions of the electromagneticradiation detected by each of the plurality of sensors yields a uniquesignal signature for a range of dose volumes remaining in the drugdelivery device 310.

In some embodiments, a plurality or pseudo-plurality of light sourcesand a plurality of sensors are alternately disposed both sides of a drugdelivery device. As shown in FIG. 8, a dose measurement system 400includes a plurality or pseudo-plurality of light sources 444 and aplurality of sensors 454. The drug delivery device 410 includes ahousing 412 and an actuator 414 that collectively define an internalvolume (e.g., a reservoir) for containing a drug. The drug deliverydevice 410 also includes an injector 416 for communicating the drug to apatient. The dose measurement system 400 is configured such that theplurality or pseudo-plurality of light sources 444 and the plurality ofsensors 454 are disposed on both sides of the drug delivery device. Inother words, each side of the drug delivery device 410 has a pluralityor pseudo-plurality of light sources 444 and a plurality of sensors 454.For example, a light guide may be shaped (e.g., as a helix) andconfigured to wind around the housing with openings to distributeelectromagnetic radiation from opposite sides of the drug deliverydevice 410. This may be advantageous as emission and detection ofelectromagnetic radiation is now performed from both sides of the drugdelivery device 410, which can, for example, remove any biases.

In some embodiments, at least a portion of the plurality orpseudo-plurality of light sources and/or the plurality of sensors arearranged in an angular orientation. As shown in FIG. 9, a dosemeasurement system 500 includes a plurality or pseudo-plurality of lightsources 544 and a plurality of sensors 554. The drug delivery device 510includes a housing 512 and an actuator 514 that collectively define aninternal volume (e.g., a reservoir) for containing a drug. The drugdelivery device 510 also includes an injector 516 for communicating thedrug to a patient. The dose measurement system 500 is configured suchthat the plurality or pseudo-plurality of light sources 544 and theplurality of sensors 554 are disposed on both side of the drug deliverydevice 510 and have an angular orientation with respect to alongitudinal axis of the dose measurement system 500 and drug deliverydevice 510. This orientation may ensure that the electromagneticradiation emitted/distributed by the plurality or pseudo-plurality oflight sources 544 is incident on a larger portion of the drug deliverydevice 510 than is achievable with the light source and/or light guide544 oriented in a straight line. Similarly, the plurality of sensors 554may detect a greater portion of the electromagnetic radiation. This can,for example, result in higher resolution of the sensors 554, and/orreduce the quantity or pseudo-quantity of light sources 544 and/orsensors 554 required to achieve the desired resolution.

In some embodiments, diffused exit openings of a light guide, forexample, may be used to ensure that the electromagnetic radiationemitted/distributed by the light source and/or light guide 544 isincident on a larger portion of the drug delivery device 510 than can beachievable with a narrower beam light sources 544. A diffused exitopening presents random critical angles to internal light rays, assuringthe probability of light escaping from the light guide. This may also beviewed as the diffused exit opening having random indices of refraction.The exiting light rays are disbursed at random angles into a wideradiation pattern of light.

In other words, with a wider beam emitted/distributed by the lightsource and/or light guide 544, a higher proportion of the overall drugdelivery device 510 (or of the drug reservoir) is in opticalcommunication with the light source and/or light guide 544. Since ahigher proportion of the delivery device 510 is in optical communicationwith the light source and/or light guide 544, a broader spectrum ofelectromagnetic radiation being transmitted, reflected, and/or refractedthrough the drug delivery device can increase the signal strengthdetectable by the plurality of sensors 554. Said another way,variability in the signal signatures (as opposed to increased intensityof light incident on a sensor) increases with the broadening of the beamof light incident on the delivery device, therefore increasing theresolution of the dose measurement system 500. For example, wider anglesmay increase ability to distinguish states of the drug delivery device,even though the overall intensity of light may be lower. This is becausedistinguishing states is more about optimizing how the intensity oflight changes from state to state than it is about the absoluteintensity of light.

In some embodiments, a dose measurement system is configured to detect asignal signature from a location of an actuator of a drug deliverydevice, which may be used to estimate the volume or number of dosesremaining in the drug delivery device. As shown in FIG. 10, a dosemeasurement system 600 includes a light source and/or light guide 644and a plurality of sensors 654. A drug delivery device 610 is coupled tothe dose measurement system 600. The drug delivery device 610 includes ahousing 612 and an actuator 614 that collectively define an interiorvolume (e.g. reservoir) for containing a drug. The dose measurementsystem 600 is disposed generally about the actuator 614 portion of thedrug delivery device 610 as opposed to the dose measurement systems 300,400, and 500 being disposed generally around the drug reservoir as shownin FIGS. 7-9. The light source and/or light guide 644 and sensors 654are configured and arranged in a substantially similar way as describedabove with reference to FIG. 7. Electromagnetic radiationemitted/distributed by the plurality or pseudo-plurality of lightsources 644 may be transmitted unblocked by the actuator 614, blocked bya plunger portion of the actuator 614, reflected by a body or theplunger portion of the actuator 614, and/or reflected/refracted by thehousing of the drug delivery device 610. The combination of thetransmitted, reflected, and refracted portions of the electromagneticradiation detected by the plurality of sensors 654 are then used togenerate a signal signature at a given position of the actuator 614.Displacement of the actuator 614 from a first position to a secondposition changes the transmission, reflection, and refraction pattern ofthe electromagnetic radiation detected by the sensors 654, creating aunique signal signature at each position of the actuator 614. Thissignature may be correlated to a volume or number of doses remaining inthe drug delivery device 610 (e.g., by association with a referencesignature).

Referring now to FIGS. 11A-11C, each sensor of the plurality of sensorsof a dose measurement system can detect the electromagnetic radiationemitted/distributed by at least a portion of the plurality orpseudo-plurality of light sources, and the detected electromagneticradiation may be a combination of transmitted, reflected, and refractedelectromagnetic radiation. As shown, the dose measurement system 700includes two light sources 744 a and 744 b (e.g., openings in a lightguide), and two sensors 754 a and 754 b for clarity. The dosemeasurement system 700 is coupled to a drug delivery device 710 whichincludes a housing 712 and an actuator 714 that collectively define aninternal volume (e.g., a reservoir) for containing a liquid drug. Thedrug reservoir and at least a plunger portion of the actuator 714 aredisposed substantially inside the dose measurement system 700 betweenthe light sources 744 a, 744 b and sensors 754 a, 754 b.

As shown in FIG. 11A, the plunger portion of the actuator 714 is in afirst position (position 1) such that the plunger portion is not in theline of sight of light sources 744 a and 744 b and sensors 754 a and 754b. When electromagnetic radiation is emitted/distributed by the lightsources 744 a and 744 b toward the drug delivery device 710, asignificant portion of the electromagnetic radiation is detected by thesensors 754 a and 754 b in position 1. The electromagnetic radiation mayinclude transmitted radiation, reflected radiation (e.g., by the housing712 of the drug delivery device 710), refracted radiation (e.g., by theliquid drug and/or housing), and/or multi-directionreflection/refraction because of a curved surface of the housing 712 ofthe drug delivery device 710 as described in more detail below. As shownin this example, sensor 754 a value is 15.3 and sensor 754 b value is13.7, which indicates that a significant portion of the electromagneticradiation is detected by the sensors 754 a and 754 b.

As shown in FIG. 11B, the actuator is 714 has been displaced to a secondposition (position 2) such that the plunger portion partially blocks theline of sight between the light source 744 b and the sensor 754 b. Inposition 2, a significant portion of the electromagnetic radiationemitted/distributed by the light source 744 b is blocked from reachingthe sensor 754 b by the actuator 714, but at least a portion of theelectromagnetic radiation emitted/distributed by light source 744 a canstill reach the sensor 754 b along with any multi-directionalreflected/refracted electromagnetic radiation. Furthermore, sensor 754 acan receive refracted electromagnetic radiation from light source 744 band transmitted, refracted radiation from light source 744 a. Sensor 754a also receives electromagnetic radiation reflected by a surface of theplunger that at least partially defines the drug reservoir. Therefore,at position 2 the sensor 754 a detects an electromagnetic radiationvalue of 15.5 (greater than position 1), and sensor 754 b detects anelectromagnetic radiation value of 8.8 (less than position 1). Theunique values measured at position 2 can serve as the signal signaturevalues for position 2.

As shown in FIG. 11C, the plunger portion of the actuator 714 is in athird position (position 3) such that the plunger portion of theactuator 714 completely blocks the line of sight of the sensor 754 afrom the electromagnetic radiation emitted/distributed by light source744 a, such that substantially no transmitted and or reflected radiationfrom light source 744 a can reach the sensor 754 a. A portion of thetransmitted electromagnetic radiation emitted/distributed by the lightsource 744 b is also blocked by at least a portion of the actuator 714,from reaching the sensor 754 b. Both the sensors 754 a and 754 b canstill receive at least a portion of the reflected and refracted portionsof the electromagnetic radiation emitted/distributed by any of the lightsources 744 a and/or 744 b. Therefore, at position 3 the sensor 754 adetects an electromagnetic radiation value of 2.2 (less than positions 1and 2), and sensor 754 b detects an electromagnetic radiation value of12.0 (less than position 1, but greater than position 2). The uniquevalues measured at position 3 can serve as the signal signature valuesfor position 3.

Referring now to FIG. 12, a cross section of the dose measurement system700 taken along line AA in FIG. 11A is shown to illustrate the lensingeffect caused by the curvature of the drug reservoir. As shown, a lightray emitted/distributed at a zero degree angle by light source 744 b istransmitted without bending toward the sensor 754 b. Two more light raysemitted/distributed by the light source 744 b, at an angle away from thetransmitted ray, are caused to refract (bend) toward the transmitted rayas they enter the drug reservoir because the liquid drug has a higherrefractive index than air. This phenomenon is referred to herein as “alensing effect,” which can result in focusing of the light rays towardthe sensor 754 b. A fourth ray is emitted/distributed at an anglefurther away from the transmitted ray such that it refracts at theair/drug interface, and then is further reflected by an internal surfaceof the housing 712 of the drug delivery system 710 such that it isincident on the sensor 754 b. A fifth ray is emitted/distributed at anangle, such that even after refraction it is not incident on the sensor754 b. As described above, the combination of these rays yields adetected electromagnetic radiation value of 15.3 by sensor 754 a and13.7 by sensor 754 b. These unique values measured at position 1 canserve as the signal signature values for position 1.

Referring now to FIG. 13, a cross-section of the dose measurement system700 taken along line BB in FIG. 11C is shown to illustrate effect of theactuator 714 on the transmission of light. As shown, a light rayemitted/distributed at a zero degree angle by light source 744 b isblocked by a portion of the actuator 714. Two more light raysemitted/distributed by the light source 744 b, at an angle away from thetransmitted ray, pass unrefracted (refraction through the housing isignored) through the portion of the housing 712 of the drug deliverydevice 710 (there is no drug in this portion of the device 710) and areincident on the sensor 754 b. A fourth ray is emitted/distributed by thelight source 744 b at an angle, such that it is internally reflected bythe housing 712 and is incident on sensor 754 b, while a fifth ray isinternally reflected by the housing 712 but is not incident on thesensor 754 b. The combination of these rays yields a detectedelectromagnetic radiation value of 2.2 by sensor 754 a and 12.0 bysensor 754 b. These unique values measured at position 3 can serve asthe signal signature values for position 3. It is to be noted thatalthough the line of sight of sensor 754 a is completely blocked fromlight source 744 a, reflected and refracted portions of theelectromagnetic radiation still contribute to generation of a positivevalue.

Although the sensor values for particular positions are described asbeing absolute values, individual sensor values relative to other sensorvalues may be used to infer and/or determine the volume of liquidremaining in the drug reservoir. For example, sensor 754 a having aparticular value that is different from sensor 754 b value by a certainamount or a certain percentage may be indicative of a position/drugvolume remaining. Furthermore, a sensor value relative to two or moreother sensor values may be used to generate a calibration curve of adrug delivery device 710.

A unique signal signature obtained at various configurations pertainingto the volume of dose dispensed by a drug delivery device may be used toobtain a reference signature (calibration curve) of the dose measurementsystem. FIG. 14 shows an example of a reference signal signatureobtained for a drug delivery device using a dose measurement system thatincludes a total of seven sensors. The dose measurement system may beany dose measurement system as described herein. The electromagneticradiation signature detected by each of the plurality of sensors for arange of dose volumes dispensed is stored and used to create thereference signature. As can be seen from the reference signature whenthe drug delivery device is almost full, sensor 1 records low amplitudeof electromagnetic radiation, while sensor 7 records very high amplitudeof electrode and all other sensors detect some intermediate signalsignature. In contrast, when the drug delivery is completely empty,sensor 1 records very high amplitude of electromagnetic radiation, whilesensor 7 records low amplitude and all other sensors detect someintermediate signal signature.

Sensor 8 detects a uniform sensor signal for a substantial portion ofthe dose delivered, until the almost all the dose has been delivered orthe drug delivery device is almost empty. In some embodiments, thesensor 8 is used as the volume critically low sensor to indicate, forexample, that the drug delivery device is nearly or completely empty. Insome embodiments, the sensor 8 also is used as a usability metric sensorto detect if, for example, a drug delivery device is coupled to the dosemeasurement system and/or an injector included in the drug deliverydevice is present or not.

Therefore in this manner, the signal value recorded from all sensors fora range of drug volumes remaining yields the signal signature for theentire volume of drug in the drug delivery device. The range of drugvolumes used for obtaining the signal signature may include, forexample, drug delivery device completely full, drug delivery devicecompletely empty, and a sufficient number of intermediate signatures(e.g., a signature obtained every unit of the total fluid dispensed,inclusive of all percentages there between).

In some embodiments, the reference signature is corrected for backgroundlight. For example a background signature can be detected by detectingthe signal signature from the plurality of sensors in a dark state ofthe light source. The signal signature may be compared with thebackground signature to remove background noise. In some embodiments,the signal signature is associated with the reference signature todetermine a drug volume in the drug delivery device, using probabilisticmatching algorithms. In some embodiments, the plurality orpseudo-plurality of light sources and the plurality of sensors areconfigured such that the dose measurement system can detect the volumeof drug in the drug delivery device with a resolution of 1 unit of drug,and/or position of a plunger portion of an actuator disposed in the drugdelivery device 110 with a resolution of 100 micrometers, 110micrometers, 120 micrometers, 130 micrometers, 140 micrometers, 150micrometers, 160 micrometers, 170 micrometers, 180 micrometers, or 200micrometers, inclusive of all ranges therebetween.

FIG. 15 illustrates a flow diagram showing a method 800 for measuring avolume or number of doses remaining in a drug delivery device using anyof the dose measurement systems described herein. A user attaches a dosemeasurement system to a drug delivery device 802. A plurality of sensorsdisposed in the dose measurement system scan the drug delivery device todetermine the volume or number of doses remaining 804. For example, aprocessing unit of the dose measurement system can associate the signalsignature detected by the plurality of sensors with a referencesignature to determine the volume or number of doses remaining. Thesensor data is recorded on an onboard memory 806, such as an RFID chipand/or a memory that is part of the processing unit of the dosemeasurement system. The dose measurement system alerts the user if thevolume or number of doses remaining is critically low 808. Audio,visual, and/or tactile alerts may be used to alert the user. Acommunications module of the dose measurement system searches for anexternal device 810. For example, a Bluetooth® wireless technologyconnection may be activated to search for the external device, such as asmart phone app, a local computer or a remote server. The dosemeasurement system pairs with the external device and logs remainingvolume or dose data on the external device and/or receives any firmwareupdates 812. Optionally, the dose measurement system also may alert auser when it is time to take a dose 814. After dose data has beenrecorded and transmitted to an external device, the user can remove thedose measurement system from the drug delivery device 816. The user theninjects a pre-determined volume of the dose using the drug deliverydevice 818. The user finally replaces the dose measurement system on thedrug delivery device 820. The method 800 can then be repeated.

FIG. 16 illustrates a flow diagram showing a method 900 for conservingpower when the dose measurement system is not in use. The method 900described herein may be used with any of the dose measurement systemsdescribed herein. In a first step, a detection mechanism of the dosemeasurement system checks for a drug delivery device 902. The drugdelivery device can either be coupled or uncoupled to the dosemeasurement system 904. If the drug delivery device is not attached, thedose measurement system automatically checks for outstanding data in thememory to be logged to an external device or the user can activate acommunications module of the dose measurement system 906. In someembodiments, the communications module is only activated when the dosemeasurement system is attached to a drug delivery device. The dosemeasurement system then determines if there is onboard data to be loggedand if an external device was found 908. If there is no onboard data tobe logged and no external device was found, the dose measurement systemgoes into a power save mode for a predefined time “X” 910. For example,a processing unit of the system can turn off a communications module ofthe dose measurement system and/or turn off the electronics controllinga light source and/or plurality of sensors of the dose measurementsystem. Time “X” may be, for example, 1 minute, 10 minutes, 1 hour, orany time therebetween. Alternatively, if there is data to be logged andan external device was found, the dose measurement system pairs with theexternal device and logs data on the external device and/or receives anyfirmware updates from the external device 912. The dose measurementsystem can then go into the power save mode 910. If instead a drugdelivery device was found to be attached to the dose measurement system904, the dose measurement system scans the drug delivery device andcollects signal from all of the plurality of sensors 914. The signalfrom each of the plurality of sensors may be used to create a signalsignature corresponding to the volume or number of doses remaining inthe drug delivery device. A processing unit of the dose measurementsystem compares the signal signature with a reference signature toestimate the volume or number of doses remaining in the drug deliverydevice 916. The dose measurement system determines if the dose injectedwas greater than zero 918. If the dose injected was greater than zero,the dose measurement system time stamps and stores the dose on anonboard memory 920. The dose measurement system then goes into the powersave mode for the time “X” 910. If the dose injected was not greaterthan zero 918, than the dose measurement system directly goes into thepower save mode for the time “X” 910.

In some embodiments, any of the dose measurement systems describedherein may be associated with a health management system to manage thehealth of a patient suffering from Type I or II diabetes. FIG. 17 showsa schematic block diagram of a health management system 1000 formanaging the health of a diabetic user U. In some embodiments, thehealth management system includes a smart phone application. In someembodiments, the health management system includes a local computerand/or a remote server. The health management system is in two-waycommunication with a dose measurement system 1100 that may be reversiblycoupled to a drug delivery device 1110. The drug delivery device 1110may be an insulin injection pen or syringe for administering insulin toa user U. The dose measurement system also may communicate informationto a user or receive an input from the user. The health managementsystem 1000 is configured to receive the user exercise data E and dietdata D. The health management system 1000 is also configured to receiveblood glucose data from a blood glucose sensor 1200. The healthmanagement system 1000 can further be configured to receive user healthdata from a home health monitor 1300 (e.g., weight, blood pressure, EKG,oxygen saturation, actigraphy measures, pulmonary function, waterretention, temperature, etc.). The health management system 1000 may bein two-way communication with a network 1400. The network can be, forexample, a remote server or a call center. The network 1400 also may bein two-way communication with a monitor M and an authorized drugdispenser DD. The monitor M may be a doctor, a care giver, a pharmacy,and/or a clinical trial manager. The authorized drug dispenser DD may bea pharmacy or a clinical trial manager.

In some embodiments, the dose measurement system 1100 communicates tothe health management system the insulin volume or number of insulindoses remaining in and/or the insulin dose delivered to the user U bythe drug delivery device 1110. In some embodiments, the healthmanagement system also includes a memory for storing the user U insulindose regimen and/or any other medication schedule. The user U medicationregimen may be communicated to the health management system 1100 by, forexample, the monitor M and/or the authorized drug dispenser DD throughthe network 1400. In some embodiments, the health management system 1100is used to process user U health data, for example, user U blood glucoselevels, exercise data E, diet data D, and/or home health monitored datato determine the status of patient health. In some embodiments, thehealth management system 1000 is configured to compare dose delivered toa patient with a patient medication schedule to monitor compliance. Insome embodiments, the health management system can communicate the userhealth and dose information to the monitor M through the network 1400.The monitor M can analyze user U health data and determine if anychanges to the patient medication plan, for example, insulin and/or anyother medication dosage needs to be made. If a change is required, insome embodiments, the monitor M can communicate any changes to theuser's U medication regimen to the authorized drug dispenser DD. In someembodiments, the monitor M also communicates this information to thehealth management system 1100 through the network 1400. In someembodiments, the health management system 1100 can update and store theuser U medication regimen and also communicate to the dose measurementsystem 1100, the user U new medication regimen. The user U can thenaccess the dose measurement system 1400 to obtain the new measurementplan, for example, new insulin dosage. In this manner, a diabetic user'sU health may be monitored and managed and the user's U medicationschedule may be dynamically personalized to the user U. In someembodiments, health management system also may communicate the user Uhealth and medication history on a periodic basis. The health andmedication history may be used, for example, to inform the user U of anychanges that need to be made to improve the user's U overall health. Themedication history also may be communicated to the monitor M to analyzethe user's U progressive health.

In some embodiments, a light module includes a single light source and alight guide for transporting, distributing, and/or redirecting lightfrom the single light source. For example, FIGS. 18-24 are various viewsof a dose measurement system 1500. The dose measurement system 1500includes a lighting module 1540, a sensing module 1550, a processingunit (not shown), a communications module 1570, and a power source 1586in accordance with some embodiments. The lighting module 1540 mayinclude a light source 1548 and a light guide 1546. The sensing module1550 may include a plurality of sensors 1554. The dose measurementsystem 1500 may be configured to be coupleable to a drug delivery device(not shown) (also referred to herein as an “injection pen”). The drugdelivery device may be configured to deliver a predefined quantity of adrug (e.g., a dose) to a patient. Examples of the drug delivery deviceinclude insulin injection pens that may be used by a patient toself-administer insulin. The drug delivery device may have the same orsimilar structure and function as the drug delivery device 210 describedabove with reference to the dose measurement system 200 shown in FIGS.2-4. For example, the drug delivery device may include a housing, anactuator, and an injector. The housing may be relatively opaque, suchthat it only allows select wavelengths of electromagnetic radiation tobe transmitted therethrough (e.g., infrared or microwave radiation). Thehousing defines an internal volume (e.g., reservoir) for storing a drug.The actuator may include a plunger portion in fluid communication withthe drug and configured to communicate a predefined quantity of drug tothe patient. The actuator may be configurable (e.g., by the user) todispense variable quantities of the drug. The injector is configured topenetrate a user's skin for intramuscular, subcutaneous, and/orintravenous delivery of the drug.

FIG. 18 is a perspective view of the dose measurement system 1500. Asshown in FIG. 18, the dose measurement system 1500 includes a housing1520 that includes a first housing portion 1522 (also referred to hereinas “first housing 1522”) and a second housing portion indicated at 1524(also referred to herein as “second housing 1524”). At least a portionof the second housing portion 1524 may be configured to be disposedwithin an internal volume defined by the first housing portion 1522. Thefirst housing portion 1522 and the second housing portion 1524 may beremovably or fixedly coupled together by, for example, gluing, hotwelding, a snap-fit mechanism, screws, or by any other suitable couplingmeans. The housing 1520 may be made from a rigid, light weight, andopaque material, such as polytetrafluoroethylene, high densitypolyethylene, polycarbonate, another plastic, acrylic, sheet metal, anyother suitable material, or a combination thereof. The housing 1520 alsomay be configured to shield the internal electronic components of thedose measurement system 1500 from environmental electromagnetic noise.For example, the housing may include an insulation structure (not shown)that is, for example, lined with aluminum or any other metal sheet orfoil that can serve as an electromagnetic shield.

FIG. 19 is an exploded perspective view of the dose measurement system1500. As shown in FIG. 19, the first housing portion 1522 defines aninternal volume for substantially housing the lighting module 1540, thesensing module 1550, the processing unit, the communications module1570, the power source 1586, and at least a portion of the secondhousing portion 1524. The second housing portion 1524 defines a bore1526, shaped and sized to receive at least a portion of the drugdelivery device. For example, the bore 1526 may be shaped and sized toreceive only the drug containing portion of the housing and the injectorof the drug delivery device. The bore 1526 may be configured to receivethe drug delivery device in a preferred orientation, such as a preferredradial orientation. In some embodiments, the bore 1526 is in closetolerance with the diameter of the drug delivery device, for example, toform a friction fit with the drug delivery device. In some embodiments,the bore 1526 includes one or more notches, grooves, detents, any othersnap-fit mechanism, and/or threads, for removably coupling the drugdelivery device to the second housing 1524. In some embodiments, thesecond housing portion 1524 includes one or more alignment features toallow the drug delivery device to be coupleable with the dosemeasurement system 1500 in a predetermined radial orientation.

FIG. 20 is an exploded top view of the dose management system 1500. Asshown in FIG. 20, the first housing 1522 includes an opening 1530 forreceiving at least a portion of the communications module 1570 such as,for example, a communication interface to provide wired communicationwith an external device and/or an interface for charging the powersource 1586. In some embodiments, the first housing 1522 also includesfeatures (e.g., recesses, apertures, cavities, etc.) for receiving aportion of the drug delivery device such as the injector. In someembodiments, the housing 1520 also includes a detection mechanism (notshown) to detect if the drug delivery device has been coupled to thedose measurement system 1500 (e.g., a push switch, a motion sensor, aposition sensor, an optical sensor, a piezoelectric sensor, an impedancesensor, or any other suitable sensor). The housing 1520 may berelatively smooth and free of sharp edges. In some embodiments, thehousing 1520 is shaped to resemble a pen cap that has a form factor thatoccupies minimal space (e.g., can fit in the pocket of a user). In someembodiments, the housing 1520 also includes features (e.g., clips forattaching to a user's shirt pocket) and/or other ornamental features. Insome embodiments, the dose measurement system 1500 also may serve as areplacement cap for the drug delivery device.

The processing unit may include a PCB (not shown) and a processor (notshown). The processing unit may be the same or similar to the processingunit 260 described above with reference to the dose measurement system200 described above and will not be further described herein. Thecommunications module 1570 may be the same as or similar to thecommunications module 270 described above with reference to the dosemeasurement system 200 and will not be further described herein. Forexample, the communications module 1570 may include a speaker 1575 forproviding audible alerts or messages to the user, including, but notlimited to, dose reminders, reinforcement messages, and/or a microphone(not shown) for receiving audio input from the user. The power source1586 may be any power source that can be used to power the dosemeasurement system 1500. The power source 1586 may be the same orsimilar to the power source 286 described above with respect to the dosemeasurement system 200 and will not be further described herein. In someembodiments, as shown in FIG. 20, the dose measurement system 1500includes a capacitor 1587.

FIG. 21 is a perspective view of the light guide 1546 of the lightmodule 1540 according to an embodiment. In some embodiments, the lightguide 1546 is an internally reflective light tube/pipe and/or otherlight distribution member) for transporting and/or distributing light.In some embodiments, the light guide 1546 is formed from moldedtransparent plastic, such as, for example, polycarbonate. In otherembodiments, the light guide 1546 is formed of one or more other opticalgrade materials such as acrylic resin, polycarbonate, epoxies, andglass. In some embodiments, the light guide 1546 can be, for example,injection molded. The light guide 1546 may be a monolithic structure.Said another way, the light guide 1546 may be formed from one piece ofmaterial.

The light guide 1546 may be configured to transport electromagneticradiation (e.g., light) from the light source 1548 toward the sensormodule 1550 with minimal loss by means of total internal reflection. Thelight guide 1546 may have any suitable shape that allows for thecollection of electromagnetic radiation from the light source 1548 andoutput of electromagnetic radiation toward the sensor module 1550. Forexample, as shown in FIG. 19, the light guide 1546 may include an endwall 1545, a first wall 1547, and a second wall indicated at 1549. Thefirst wall 1547 may be angled relative to the second wall 1549 such thatthe first wall 1547 is configured to reflect electromagnetic radiationtoward the second wall 1549. Said another way, the light guide 1546 maybe shaped as a wedge. For example, FIG. 22 is a schematic side viewillustration of the light guide 1546. As shown in FIG. 22, a first lightray L₅, a second light ray L6, and a third light ray L7 are emitted by asingle light source 1548 through the end wall 1545. Each of the firstlight ray L₅, the second light ray L6, and the third light ray L7 arereflected by the first wall 1547 toward the second wall 1549 and out ofthe light guide 1546 via the second wall 1549.

The light guide 1546 and the light source 1548 may be mounted on, orotherwise disposed on, the second housing portion 1524. Specifically,the light guide 1546 may be mounted on, or otherwise disposed on, anaperture 1528 of the second housing portion 1524. In some embodiments,light guide 1546 is arranged such that, when the portion of the drugdelivery device that defines the internal volume of the housing holdingthe drug is coupled with the dose measurement system 1500, the lightguide 1546 can illuminate the entire internal volume. While the lightguide 1546 is shown and described as having a wedge shape, in someembodiments the light guide 1546 is formed in any suitable shapeconfigured for even dispersal of electromagnetic radiation, includingbut not limited to straight, bent, and triangular.

In some embodiments, the light guide 1546 includes a reflective material(not shown) on a portion of the light guide 1546 to directelectromagnetic radiation traveling through the light guide 1546. Forexample, reflective material may be disposed on the first wall 1547 todirect electromagnetic radiation through the second wall 1549 toward theinterior of the second housing 1524, the drug delivery device, and/orthe sensors 1554 of the sensor module 1550.

The light source 1548 may be a single LED. The LED may be any suitabletype of LED, such as, for example, an infrared (IR) LED. The angle ofoutput of the light source 1548 may be arranged relative to the end wall1545 of the light guide 1546 such that electromagnetic radiation fromthe light source 1548 can travel through and be distributed by the lightguide 1546. For example, the light source 1548 may be arranged at anangle relative to the end wall 1545 of the light guide 1546 such thatthe angle is optimized for even distribution of electromagneticradiation from the second wall 1549 toward the interior of the secondhousing 1524 and the sensors 1554 of the sensor module 1550.

In some embodiments, the light source 1548 is configured to produce anelectromagnetic radiation of a wavelength that is capable of beingdispersed by the light guide 1546 and penetrating through the housing ofthe drug delivery device, the drug contained therein, and/or a portionof the housing 1520. For example, infrared radiation or microwaveradiation can penetrate many of the plastic materials that are commonlyused in manufacturing drug delivery devices (e.g., injection pens). Insome embodiments, an electromagnetic radiation has a frequency that canpenetrate through the internal components of the drug delivery device,including, but not limited to, the plunger portion of the actuator. Insome embodiments, the light guide 1546 is configured to produce one ormore wide beams of electromagnetic radiation (e.g., via diffused exitopenings). Said another way, the electromagnetic radiation cone of eachopening in the light guide 1546 may have a wide angle. In someembodiments, the light source 1548 is configured to emit pulses ofelectromagnetic radiation (e.g., a series of less than 100 microsecondpulses or pulses about 200 microseconds apart plus or minus 100microseconds).

The plurality of sensors 1554 of the sensing module 1550 are mounted on,or otherwise disposed on, a PCB 1552. The PCB 1552 may be any standardPCB made by any commonly known process and may be the same or similar tothe PCB 252 described above with reference to the dose management system200. The sensing module 1550 or, specifically, the plurality of sensors1554, may be the same as or similar to the sensing module 250 or theplurality of sensors 254, respectively, described above with referenceto the dose management system 200. The plurality of sensors 1554 may beany optical sensors (e.g., photodiodes) optically coupleable with thelight guide 1546 and configured to detect at least a portion of theelectromagnetic radiation distributed by the light guide 1546. Theelectromagnetic radiation may be transmitted radiation, refractedradiation (e.g., refracted through air, drug, and/or body of drugdelivery device), reflected radiation (e.g., reflected from a wall ofthe housing 1520 and/or internally reflected from a wall of the drugdelivery device), and/or multi-directional refraction/reflection (e.g.,caused by a lensing effect of a curved surface of the housing and/or thedrug reservoir). The transmitted, refracted, and/or reflectedelectromagnetic signal received by the plurality of sensors 1554 may beused to create a signal signature (e.g., by the processing unit). Forexample, the signal signature can then be associated with a referencesignature to determine the volume or number of doses remaining in thedrug delivery device. In some embodiments, the signal response of thesensors 1554 is used to measure usability metrics such as, for example,determining the presence of the injector of the drug delivery device,and/or determining whether the drug delivery device is coupled oruncoupled to the dose measurement system 1500. In some embodiments, thenumber of the plurality of sensors 1554 is one or greater than one. Insome embodiments, the light guide 1546 and/or sensors 1554 are arrangedin an inclined orientation. In some embodiments, the plurality ofsensors are disposed in a substantially straight line that issubstantially parallel to the elongate axis of the light guide.

FIGS. 23 and 24 are a cross-sectional perspective view and across-sectional side view, respectively, of the dose measurement system1500. As shown in FIGS. 23 and 24, the second housing 1524 can defineapertures 1528 for receiving at least a portion of the light guide 1546of the lighting module 1540 and/or sensors 1554 of the sensing module1550. The apertures 1528 may be configured to provide mechanical supportfor the light guide 1546 and/or sensors 1554, or can serve as analignment mechanism for the lighting module 1540 and/or sensing module1550.

As described herein, the electromagnetic radiation signal received bythe plurality of sensors 1554 of the sensing module 1550 may include acombination of the transmitted, refracted and reflected portions of theelectromagnetic radiation distributed by the light guide 1546. A uniquesignal signature is produced by the combination of the portions of theelectromagnetic radiation at different dose volumes remaining, and/orthe actuator position of the drug delivery device. This signal signaturemay be compared with a reference signal signature database (alsoreferred to herein as “a calibration curve”) to obtain the volume ornumber of doses remaining in drug delivery device, as described infurther detail herein.

As described above, the light module 1540 includes only a single lightsource 1548 in combination with the light guide 1546. Compared toembodiments that include multiple discrete light sources which each havecomponent-to-component variation, the use of a single light source 1548in combination with the light guide 1546 reduces thecomponent-to-component variability of the light module 1540 to zero.Said another way, the use of the light module 1540, and particularly asingle light source 1548, eliminates the need to compensate for thevariation between multiple discrete light sources. Additionally, thelight guide 1546 is configured, as described above, to reduce oreliminate the variation of electromagnetic radiation (i.e. theelectromagnetic radiation distribution profile from the light guide1546) along the length of the device among separate and distinct dosemeasurement systems 1500. The light guide 1546 may be arranged and/orformed such that is distributes electromagnetic radiation in arepeatable profile. Similarly, the light source 1548 may be arrangedsuch that the light source 1548 directs electromagnetic radiation intothe end wall 1545 of the light guide 1546 at substantially the sameangle in all dose measurement systems 1500. The light guide 1546 canthen distribute the electromagnetic radiation from the light source 1548across the length of the light guide 1546 to create a “bar” of lightwhere the proportion of electromagnetic radiation received fromdifferent areas of the light guide 1546 is substantially equal and/orrepeatable.

Consider two dose measurement systems similar to system 1500: a firstdose measurement system 1500 a and a second dose measurement system 1500b. Due to possible variation in the brightness of light sources (e.g.,LEDs) used as the single light source 1548, the magnitude of theelectromagnetic radiation (e.g., the brightness of the light) receivedby the plurality of sensors 1554 a from the light guide 1546 a in thefirst dose measurement system 1500 a can vary from the magnitude of theelectromagnetic radiation received by the plurality of sensors 1554 bfrom the light guide 1546 b in the second dose measurement system 1500b. This variation in the magnitude of the electromagnetic radiation fromthe light source 1548 may be compensated for by the sensing moduleand/or the processing module easily because each of the plurality ofsensors 1554 a in the first dose measurement system 1500 a (and each ofthe plurality of sensors 1554 b in the second dose measurement system1500 b) will detect the same percentage change of light (e.g., theplurality of sensors 1554 a in the first dose measurement system 1500 amay receive 20% more light from a 20% brighter light source 1548). Forexample, the first dose measurement system 1500 a may include sixsensors that each measure a brightness value of 1.2 in a configurationwhere a drug delivery device and/or the second housing do not interferewith the travel of light from the first light guide to the plurality ofsensors. The second dose measurement system 1500 b may include sixsensors that each measure a brightness value of 0.7 in a configurationwhere a drug delivery device and/or the second housing do not interferewith the travel of light from the first light guide to the plurality ofsensors. Therefore, the single light source of the second dosemeasurement system 1500 b is 7/12 the brightness value of the singlelight source of the first dose measurement system 1500 a, but thedistribution profile is the same between the two dose measurementsystems. Because the distribution profile is the same, the sensingmodule 1550 of each dose measurement system can produce the same signalsignature for each dose measurement system.

FIG. 25A is a schematic illustration of a dose measurement system 1600a. As shown in FIG. 25A, a dose measurement system 1600 a includes alight guide 1646 a and a plurality of sensors 1654. While some of thetransmitted and reflected portion of the electromagnetic radiationdistributed by the light guide 1646 a is shown, the refractive portionis not shown for clarity. A drug delivery device 1610 is coupled to thedose measurement system 1600 a. The drug delivery device 1610 includes ahousing 1612 and an actuator 1614 that collectively define an internalvolume (e.g., a reservoir) for containing a drug. The drug deliverydevice 1610 also includes an injector 1616 for communicating the drug toa patient. The dose measurement system 1600 a is configured such thatthe light guide 1646 a is disposed on a first side of the housingoriented toward the drug delivery device 1610 and the plurality ofsensors 1654 are disposed on a second side of the housing such that eachof the plurality of sensors 1654 is substantially opposite to, and inoptical communication with, a portion of the light guide 1646 a. In someembodiments, the light guide 1646 a and/or the plurality of sensors 1654are disposed in a substantially linear relationship (e.g., a straightline) with respect to each other. Each of the plurality of sensors 1654receive a combination of transmitted, refracted and reflectedelectromagnetic radiation distributed by the light guide 1646 a. Thereflection portion of the electromagnetic radiation may be reflectedfrom a plunger portion of the actuator 1614, and/or reflected from ahousing of the dose measurement system 1600 a or the housing 1612 of thedrug delivery device 1610. The refraction may be from the housing 1612and/or from the liquid drug disposed in the drug delivery device 1610.The combination of the transmitted, reflected and refracted portions ofthe electromagnetic radiation detected by each of the plurality ofsensors yields a unique signal signature for a range of dose volumesremaining in the drug delivery device 1610.

FIG. 25B is a schematic illustration of a dose measurement system 1600b. As shown in FIG. 25B, the dose measurement system 1600 b is the samein structure and function to the dose measurement system 1600 a (shownin FIG. 25A), except that the dose measurement system 1600 b includes alight pipe 1646 b rather than light pipe 1646 a. The light pipe 1646 bis similar to the light pipe 1646 a except that the light pipe 1646 b iswedge-shaped.

Referring now to FIGS. 26A-26C, each sensor of a plurality of sensors ofa dose measurement system may detect the electromagnetic radiationdistributed by at least a portion of a light guide, and the detectedelectromagnetic radiation can be a combination of transmitted,reflected, and/or refracted electromagnetic radiation. As shown, a dosemeasurement system 1700 includes a light guide 1746 and two sensors 1754a and 1754 b for clarity. The dose measurement system 1700 is coupled toa drug delivery device 1710 which includes a housing 1712 and anactuator 1714 that collectively define an internal volume (e.g., areservoir) for containing a liquid drug. The drug reservoir and at leasta plunger portion of the actuator 1714 are disposed substantially insidethe dose measurement system 1700 between the light guide 1746 andsensors 1754 a, 1754 b.

As shown in FIG. 26A, the plunger portion of the actuator 1714 is in afirst position (position 1) such that the plunger portion is not in theline of sight of the light guide 1746 and sensors 1754 a and 1754 b.When electromagnetic radiation is distributed by the light guide 1746toward the drug delivery device 1710, a significant portion of theelectromagnetic radiation is detected by the sensors 1754 a and 1754 bin position 1. The electromagnetic radiation may include transmittedradiation, reflected radiation (e.g., by the housing 1712 of the drugdelivery device 1710) refraction (e.g., by the liquid drug and/orhousing), and/or multi-direction reflection/refraction (e.g., due to acurved surface of the housing 1712 of the drug delivery device 1710) asdescribed in more detail below. As shown in this example, sensor 1754 avalue is 15.3 and sensor 1754 b value is 13.7, which indicates that asignificant portion of the electromagnetic radiation is detected by thesensors 1754 a and 1754 b.

As shown in FIG. 26B, the actuator is 1714 has been displaced to asecond position (position 2) such that the plunger portion partiallyblocks the line of sight between a portion of the light guide 1746 andthe sensor 1754 b. In position 2, a significant portion of theelectromagnetic radiation distributed by the light guide 1746 is blockedfrom reaching the sensor 1754 b by the actuator 1714, but at least aportion of the electromagnetic radiation distributed by the light guide1746 can still reach the sensor 1754 b along with any multi-directionalreflected/refracted electromagnetic radiation. Furthermore, the sensor1754 a can receive refracted electromagnetic radiation from sensor 1744b and transmitted, refracted radiation from sensor 1744 a. It alsoreceives electromagnetic radiation reflected by a surface of the plungerthat at least partially defines the drug reservoir. Therefore, atposition 2 the sensor 1754 a detects an electromagnetic radiation valueof 15.5 (greater than position 1), and sensor 1754 b detects anelectromagnetic radiation value of 8.8 (less than position 1). Theunique values measured at position 2 can serve as the signal signaturevalues for position 2.

As shown in FIG. 26C, the plunger portion of the actuator 1714 is in athird position (position 3) such that the plunger portion of theactuator 1714 completely blocks the line of sight of the sensor 1754 afrom the electromagnetic radiation distributed by light guide 1746, suchthat substantially no transmitted and or reflected radiation from lightguide 1746 can reach the sensor 1754 a. A portion of the transmittedelectromagnetic radiation distributed by light guide 1746 is alsoblocked by at least a portion of the actuator 1714 from reaching thesensor 1754 b. Both the sensors 1754 a and 1754 b can still receive atleast a portion of the reflected and refracted portions of theelectromagnetic radiation distributed by the light guide 1746.Therefore, at position 3 the sensor 1754 a detects an electromagneticradiation value of 2.2 (less than positions 1 and 2), and sensor 1754 bdetects an electromagnetic radiation value of 12.0 (less than position1, but greater than position 2). The unique values measured at position3 can serve as the signal signature values for position 3.

Although not shown, the curvature of the drug reservoir can cause alensing effect in the dose measurement system 1700 that is the same asor similar to the lensing effect described above with respect to thedose measurement system 700 and with reference to FIGS. 12 and 13.Similarly as described with respect to the dose management system 700,the combination of rays that reach the sensor 1754 a and the sensor 1754b from the light guide 1756 in each configuration of the dosemeasurement system 700 with respect to the drug delivery device 1710will produce the indicated electromagnetic radiation values in FIGS.26A-26B. Also similarly as described above with respect to the dosemeasurement system 700, although the sensor values for particularpositions are described as being absolute values, individual sensorvalues relative to other sensor values may be used to infer and/ordetermine the volume of liquid remaining in the drug reservoir. Forexample, sensor 1754 a having a particular value that is different fromsensor 1754 b value by a certain amount or a certain percentage may beindicative of a position/drug volume remaining. Furthermore, a sensorvalue relative to two or more other sensor values may be used togenerate a calibration curve of a drug delivery device 1710.

FIG. 27 is an exploded perspective view of a drug delivery device 1810with a dose measurement system 1800. The dose measurement system 1800includes a lighting module 1840, a sensing module 1850, a processingunit (not shown), a communications module 1870, and a power source (notshown) in accordance with some embodiments. The dose measurement system1800 also includes a display assembly 1825 and a display lens 1827. Thedisplay assembly 1825 may include a light emitting diode (LED). Thelighting module 1840 may include a light source (not shown) and a lightguide 1846. The sensing module 1850 may include a plurality of sensors1854. The dose measurement system 1800 may be configured to be removablycoupleable to the drug delivery device 1810 (also referred to herein as“an injection pen 1810”). The drug delivery device 1810 may beconfigured to deliver a predefined quantity of a drug (e.g., a dose) toa patient. Examples of the drug delivery device 1810 include insulininjection pens that can be used by a patient to self-administer insulin.As described herein, the drug delivery device 1810 may include a housing1812, an actuator 1814, and an injector 1816. The housing 1812 may berelatively opaque, such that it only allows select wavelengths ofelectromagnetic radiation to be transmitted therethrough (e.g., infraredor microwave radiation). The housing 1810 defines an internal volume(e.g., a reservoir) for storing a drug. The actuator 1814 may include aplunger portion in fluid communication with the drug and configured tocommunicate a predefined quantity of drug to the patient. The actuator1814 may be configurable (e.g., by the user) to dispense variablequantities of the drug. The injector 1816 may be configured to penetratea user's skin for intramuscular, subcutaneous, and/or intravenousdelivery of the drug.

The dose measurement system 1800 includes a housing 1820 that includes afirst housing portion 1822 (also referred to herein as “first housing1822”) and a second housing portion indicated at 1824 (also referred toherein as “second housing 1824”). The first housing portion 1822includes a right first housing portion 1822 a and a left first housingportion 1822 b. At least a portion of the second housing portion 1824may be configured to be disposed within an internal volume defined bythe first housing portion 1822. The first housing portion 1822 and thesecond housing portion 1824 may be removably or fixedly coupled togetherby, for example, gluing, hot welding, a snap-fit mechanism, screws, orby any other suitable coupling means. Similarly, the right first housingportion 1822 a and the left first housing portion 1822 b may beremovably or fixedly coupled together by, for example, gluing, hotwelding, a snap-fit mechanism, screws, or by any other suitable couplingmeans. The housing 1820 may be made from a rigid, light weight, andopaque material, such as polytetrafluoroethylene, high densitypolyethylene, polycarbonate, another plastic, acrylic, sheet metal, anyother suitable material, or a combination thereof. The housing 1820 alsomay be configured to shield the internal electronic components of thedose measurement system 1800 from environmental electromagnetic noise.For example, the housing may include an insulation structure (not shown)that is, for example, lined with aluminum or any other metal sheet orfoil that can serve as an electromagnetic shield.

The first housing portion 1822 defines an internal volume forsubstantially housing the lighting module 1840, the sensing module 1850,the processing unit, the communications module 1870, the power source1886, the display assembly 1825, the display lens 1827, and at least aportion of the second housing portion 1824. The second housing portion1824 defines a bore 1826, shaped and sized to receive at least a portionof the drug delivery device 1810. For example, the bore 1826 may beshaped and sized to receive only the drug containing portion of thehousing 1812 and the injector 1816 of the drug delivery device 1810. Thebore 1826 may be configured to receive the drug delivery device 1810 ina preferred orientation, such as a preferred radial orientation. In someembodiments, the bore 1826 is in close tolerance with the diameter ofthe drug delivery device 1810, for example, to form a friction fit withthe drug delivery device 1810. In some embodiments, the bore 1826includes one or more notches, grooves, detents, any other snap-fitmechanism, and/or threads, for removably coupling the drug deliverydevice 1810 to the second housing 1824. In some embodiments, the secondhousing portion 1824 includes one or more alignment features to allowthe drug delivery device 1810 to be coupleable with the dose measurementsystem 1800 in a predetermined radial orientation.

The right first housing portion 1822 a and the left first housingportion 1822 b collectively define an opening 1830 for receiving atleast a portion of the communications module 1870 such as, for example,a communication interface to provide wired communication with anexternal device and/or an interface for charging the power source 1886.In some embodiments, the right first housing portion 1822 a and the leftfirst housing portion 1822 b also include features (e.g., recesses,apertures, cavities, etc.) for receiving a portion of the drug deliverydevice 1810 such as the injector 1816. In some embodiments, the housing1820 also includes a detection mechanism (not shown) to detect if thedrug delivery device 1810 has been coupled to the dose measurementsystem 1800 (e.g., a push switch, a motion sensor, a position sensor, anoptical sensor, a piezoelectric sensor, an impedance sensor, or anyother suitable sensor). The housing 1820 may be relatively smooth andfree of sharp edges. In some embodiments, the housing 1820 is shaped toresemble a pen cap that has a form factor that occupies minimal space(e.g., can fit in the pocket of a user). In some embodiments, thehousing 1820 also includes features (e.g., clips for attaching to auser's shirt pocket) and/or other ornamental features. In someembodiments, the dose measurement system 1800 also may serve as areplacement cap for the drug delivery device 1810.

The processing unit may include a PCB (not shown) and a processor (notshown). The processing unit may be the same or similar to the processingunit 1560 described above with reference to the dose measurement system1500 described above and will not be further described herein. Thecommunications module 1870 may be the same as or similar to thecommunications module 1570 described above with reference to the dosemeasurement system 1500 and will not be further described herein. Forexample, the communications module 1870 may include a speaker (notshown) for providing audible alerts or messages to the user, including,but not limited to, dose reminders, reinforcement messages, and/or amicrophone (not shown) for receiving audio input from the user. Thepower source may be any power source that can be used to power the dosemeasurement system 1800. The power source may be the same or similar tothe power source 1586 described above with respect to the dosemeasurement system 1500 and will not be further described herein. Insome embodiments, the dose measurement system 1800 includes a capacitor(not shown).

The light guide 1846 and the light source of the light module 1840 canbe the same or similar to the light guide 1546 of the light module 1540and will not be further described herein. The plurality of sensors 1854of the sensing module 1850 are mounted on, or otherwise disposed on, aPCB 1852. The PCB 1852, the plurality of sensors 1854, and the sensingmodule 1850 can the same or similar to the PCB 1552, the plurality ofsensors 1554, and the sensing module 1550 and will not be furtherdescribed herein.

The second housing 1824 can define apertures 1828 for receiving at leasta portion of the light guide 1846 of the lighting module 1840 and/orsensors 1854 of the sensing module 1850. The apertures 1528 may beconfigured to provide mechanical support for the light guide 1546 and/orsensors 1554, or can serve as an alignment mechanism for the lightingmodule 1540 and/or sensing module 1550.

FIG. 28 is an illustration of a dose measurement system 1900 that can bestructurally and/or functionally similar to the dose measurement system200 as shown in FIGS. 2-4, according to some embodiments. In someembodiments, the light guide can be disposed on a light guide axis suchthat the light guide axis is substantially parallel to a longitudinalaxis defined by the dose measurement system 1900. The light source 1944can be disposed at an angle such that the light source 1944 is facingdownward (toward the injection pen 1910) and is configured to emitelectromagnetic radiation along the light guide axis. The sensors 1954can be disposed on a sensor axis such that the sensor axis issubstantially parallel to the longitudinal axis defined by the dosemeasurement system 1900. That is light source 1944 is configured to emitelectromagnetic radiation approximately in a perpendicular direction tothe sensors 1952. Said another way, the sensors 1954 can be disposed ona first side 1955 a of the dose measurement system 1900 facing a secondside 1955 b of the dose measurement system 1900 and the light guide canbe disposed substantially parallel to the second side 1955 b of the dosemeasurement system 1900. The light source 1944 can be disposed on thesecond side 1955 b of the dose measurement system such that the lightsource 1944 is facing the injection pen 1910 and such that the lightsource 1944 can emit electromagnetic radiation along the light guide. Insome embodiments, the light source 1944 can be disposed at an angle ofabout 90 degrees, about 100 degrees, about 110 degrees, about 120degrees, about 130 degrees, about 140 degrees, about 150 degrees, about160 degrees, about 170 degrees, or about 180 degrees, inclusive of allranges therebetween with respect to the longitudinal axis of the dosemeasurement system 2800.

In some embodiments, the dose measurement system 1900 can include atleast one opening or area on the second side 1955 b of the dosemeasurement system 1900 such that the second side 1955 b is opposite toand facing the first side 1955 a of the dose measurement system 1900.The opening or area may be configured to distribute at least a portionof the electromagnetic radiation emitted by the light source 1944. Insome embodiments, the dose measurement system 1900 can include a lightguide on the second side 1955 b of the dose measurement system 1900 thatis configured to distribute at least a portion of the electromagneticradiation emitted by the light source 1944. In some embodiments, thelight guide is disposed such that the elongated axis of the light guideis substantially parallel to the sensors 1954. In some embodiments, thelight guide is disposed such that each opening or area for transmittingelectromagnetic radiation is located parallel to at least one sensor.

In some embodiments, the downward angling of the light source 1944 suchthat the light source is not directly facing the sensors 1954 can beconfigured to cause electromagnetic radiation emitted by the lightsource 1944 to be scattered. The scattered portions of theelectromagnetic radiation may be detected by the plurality of sensors1954. In some embodiments, at least a portion of the electromagneticradiation emitted by the light source 1944 may be detected by thesensors 1954. In some embodiments, the light guide and/or at least theopening or the area on the second side of the dose measurement system1900 can be configured to distribute the scattered portions of theelectromagnetic radiations in a manner such that the scattered portionsmay be detected by the sensors 1954.

While various inventive embodiments have been described and illustratedherein, those of ordinary skill in the art will readily envision avariety of other means and/or structures for performing the functionand/or obtaining the results and/or one or more of the advantagesdescribed herein, and each of such variations and/or modifications isdeemed to be within the scope of the inventive embodiments describedherein. More generally, those skilled in the art will readily appreciatethat all parameters, dimensions, materials, and configurations describedherein are meant to be exemplary and that the actual parameters,dimensions, materials, and/or configurations will depend upon thespecific application or applications for which the inventive teachingsis/are used. Those skilled in the art will recognize, or be able toascertain using no more than routine experimentation, many equivalentsto the specific inventive embodiments described herein. It is,therefore, to be understood that the foregoing embodiments are presentedby way of example only and that, within the scope of the appended claimsand equivalents thereto, inventive embodiments may be practicedotherwise than as specifically described and claimed. Inventiveembodiments of the present disclosure are directed to each individualfeature, system, article, material, kit, and/or method described herein.In addition, any combination of two or more such features, systems,articles, materials, kits, and/or methods, if such features, systems,articles, materials, kits, and/or methods are not mutually inconsistent,is included within the inventive scope of the present disclosure.

The above-described embodiments can be implemented in any of numerousways. For example, embodiments may be implemented using hardware,software or a combination thereof. When implemented in software, thesoftware code can be executed on any suitable processor or collection ofprocessors, whether provided in a single computer or distributed amongmultiple computers.

Further, it should be appreciated that a computer may be embodied in anyof a number of forms, such as a rack-mounted computer, a desktopcomputer, a laptop computer, or a tablet computer. Additionally, acomputer may be embedded in a device not generally regarded as acomputer but with suitable processing capabilities, including a PersonalDigital Assistant (PDA), a smart phone or any other suitable portable orfixed electronic device.

Also, a computer may have one or more input and output devices. Thesedevices can be used, among other things, to present a user interface.Examples of output devices that can be used to provide a user interfaceinclude printers or display screens for visual presentation of outputand speakers or other sound generating devices for audible presentationof output. Examples of input devices that can be used for a userinterface include keyboards, and pointing devices, such as mice, touchpads, and digitizing tablets. As another example, a computer may receiveinput information through speech recognition or in other audible format.

Such computers may be interconnected by one or more networks in anysuitable form, including a local area network or a wide area network,such as an enterprise network, and intelligent network (IN) or theInternet. Such networks may be based on any suitable technology and mayoperate according to any suitable protocol and may include wirelessnetworks, wired networks or fiber optic networks.

The various methods or processes outlined herein may be coded assoftware that is executable on one or more processors that employ anyone of a variety of operating systems or platforms. Additionally, suchsoftware may be written using any of a number of suitable programminglanguages and/or programming or scripting tools, and also may becompiled as executable machine language code or intermediate code thatis executed on a framework or virtual machine.

Also, various inventive concepts may be embodied as one or more methods,of which an example has been provided. The acts performed as part of themethod may be ordered in any suitable way. Accordingly, embodiments maybe constructed in which acts are performed in an order different thanillustrated, which may include performing some acts simultaneously, eventhough shown as sequential acts in illustrative embodiments.

All publications, patent applications, patents, and other referencesmentioned herein are incorporated by reference in their entirety.

All definitions, as defined and used herein, should be understood tocontrol over dictionary definitions, definitions in documentsincorporated by reference, and/or ordinary meanings of the definedterms.

The indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.”

The phrase “and/or,” as used herein in the specification and in theclaims, should be understood to mean “either or both” of the elements soconjoined, i.e., elements that are conjunctively present in some casesand disjunctively present in other cases. Multiple elements listed with“and/or” should be construed in the same fashion, i.e., “one or more” ofthe elements so conjoined. Other elements may optionally be presentother than the elements specifically identified by the “and/or” clause,whether related or unrelated to those elements specifically identified.Thus, as a non-limiting example, a reference to “A and/or B”, when usedin conjunction with open-ended language such as “comprising” can refer,in one embodiment, to A only (optionally including elements other thanB); in another embodiment, to B only (optionally including elementsother than A); in yet another embodiment, to both A and B (optionallyincluding other elements); etc.

As used herein in the specification and in the claims, “or” should beunderstood to have the same meaning as “and/or” as defined above. Forexample, when separating items in a list, “or” or “and/or” shall beinterpreted as being inclusive, i.e., the inclusion of at least one, butalso including more than one, of a number or list of elements, and,optionally, additional unlisted items. Only terms clearly indicated tothe contrary, such as “only one of” or “exactly one of,” or, when usedin the claims, “consisting of,” will refer to the inclusion of exactlyone element of a number or list of elements. In general, the term “or”as used herein shall only be interpreted as indicating exclusivealternatives (i.e. “one or the other but not both”) when preceded byterms of exclusivity, such as “either,” “one of” “only one of” or“exactly one of.” “Consisting essentially of” when used in the claims,shall have its ordinary meaning as used in the field of patent law.

As used herein in the specification and in the claims, the phrase “atleast one,” in reference to a list of one or more elements, should beunderstood to mean at least one element selected from any one or more ofthe elements in the list of elements, but not necessarily including atleast one of each and every element specifically listed within the listof elements and not excluding any combinations of elements in the listof elements. This definition also allows that elements may optionally bepresent other than the elements specifically identified within the listof elements to which the phrase “at least one” refers, whether relatedor unrelated to those elements specifically identified. Thus, as anon-limiting example, “at least one of A and B” (or, equivalently, “atleast one of A or B,” or, equivalently “at least one of A and/or B”) canrefer, in one embodiment, to at least one, optionally including morethan one, A, with no B present (and optionally including elements otherthan B); in another embodiment, to at least one, optionally includingmore than one, B, with no A present (and optionally including elementsother than A); in yet another embodiment, to at least one, optionallyincluding more than one, A, and at least one, optionally including morethan one, B (and optionally including other elements); etc.

In the claims, as well as in the specification above, all transitionalphrases such as “comprising,” “including,” “carrying,” “having,”“containing,” “involving,” “holding,” “composed of,” and the like are tobe understood to be open-ended, i.e., to mean including but not limitedto. Only the transitional phrases “consisting of” and “consistingessentially of” shall be closed or semi-closed transitional phrases,respectively, as set forth in the United States Patent Office Manual ofPatent Examining Procedures, Section 2111.03.

1-52. (canceled)
 53. An apparatus, comprising: a housing supporting alight source, a light guide, and a plurality of sensors, the housingconfigured to be removably coupled to a container such that the lightguide is positioned to distribute a portion of electromagnetic radiationemitted by the light source and direct the distributed electromagneticradiation through the container to be detected by the plurality ofsensors, the container containing a volume of a drug; and a processingunit disposed in the housing and configured to: cause the light sourceto emit the electromagnetic radiation into the light guide such that thelight guide distributes the portion of the electromagnetic radiation anddirects the distributed electromagnetic radiation toward the container;receive, from each of the plurality of sensors, data representative of aportion of the distributed electromagnetic radiation detected by thatsensor; generate, using the received data, a signal signaturerepresentative of the detected electromagnetic radiation; determine doseinformation associated with the drug based on at least the signalsignature; and communicate, via a communications interface operativelycoupled to the processing unit, the dose information to a compute deviceexternal to the housing.
 54. The apparatus of claim 53, wherein theprocessing unit is configured to determine the dose information based onthe signal signature and information derived from electromagnetic energysignatures previously recorded for a range of volumes of the drug in thecontainer.
 55. The apparatus of claim 53, wherein the processing unit isfurther configured to compare the signal signature to informationobtained from electromagnetic radiation previously detected by theplurality of sensors for a range of volumes of the drug in thecontainer.
 56. The apparatus of claim 53, wherein the dose informationincludes at least one of: a volume of the drug in the container, avolume of a dose of the drug dispensed from the container, a number ofdoses of the drug in the container, a number of doses of the drugdispensed from the container, a type of the drug, a temperature of thedrug, an expiration of the drug, manufacturer information associatedwith the container, an attachment state of a needle to the container, atime of last dose, or a scheduled time for a dose.
 57. The apparatus ofclaim 53, wherein the container is an injection pen, and the housing isa pen cap.
 58. The apparatus of claim 53, further comprising a memorydisposed in the housing and configured to store for a predefined periodof time at least one of: the received data, or the signal signature. 59.The apparatus of claim 53, wherein the processing unit is configured tocommunicate the dose information to the compute device such that thecompute device, in response to receiving the dose information, presentsthe dose information to a user.
 60. The apparatus of claim 53, furthercomprising an output unit, the processing unit configured to present,via the output unit, an output based on the dose information to a user.61. The apparatus of claim 53, further comprising a user input interfaceoperatively coupled to the processing unit, the processing unitconfigured to: receive an input from the user input interface; and storethe input in a memory operatively coupled to the processing unit orcontrol an operation of at least one of the light source or thecommunications interface based on the input.
 62. The apparatus of claim53, wherein the light guide has an elongate axis that extends along alongitudinal length of the housing.
 63. The apparatus of claim 62,wherein the plurality of sensors are disposed in a substantiallystraight light that is substantially parallel to the elongate axis ofthe light guide.
 64. A system, comprising: a dose measurement deviceremovably coupleable to a container containing a volume of a drug, thedose measurement device including: a light source configured to emitelectromagnetic radiation; a light guide configured to receive theelectromagnetic radiation and distribute at least a portion of theelectromagnetic radiation and direct the distributed electromagneticradiation toward the container; and a plurality of sensors eachconfigured to detect at least a portion of the distributedelectromagnetic radiation; and a compute device operatively coupled tothe dose measurement device, the compute device configured to: receive,from the dose measurement device, data representative of the detectedelectromagnetic radiation; and determine dose information associatedwith the drug in the container based on at least the data representativeof the detected electromagnetic radiation.
 65. The system of claim 64,wherein the compute device is a first compute device, the first computedevice further operatively coupled to one or more monitoring devicesseparate from the dose measurement device, the compute device furtherconfigured to: receive user health data from the one or more monitoringdevices; analyze the user health data to determine whether to change adosage plan associated with a user; and in response to determining tochange the dosage plan, communicate a change to the dosage plan to asecond compute device such that the second compute device can presentthe change to one or more users.
 66. The system of claim 65, wherein theuser health data includes at least one of: blood glucose data, weightdata, blood pressure data, electrocardiogram (EKG) data, oxygensaturation data, activity data, pulmonary function data, water retentiondata, temperature data, or food intake data.
 67. The system of claim 64,wherein the dose information includes at least one of: a volume of thedrug in the container, a volume of a dose of the drug dispensed from thecontainer, a number of doses of the drug in the container, a number ofdoses of the drug dispensed from the container, a type of the drug, atemperature of the drug, or an expiration of the drug.
 68. The system ofclaim 64, wherein the compute device is further configured to determinethat the dose measurement device has been coupled to the container basedon at least the data representative of the detected electromagneticradiation.
 69. A method, comprising: causing a light source to emitelectromagnetic radiation into a light guide such that the light guidedistributes a portion of the electromagnetic radiation and directs thedistributed electromagnetic radiation toward a container including avolume of a drug; receiving, from each of a plurality of sensors, datarepresentative of a portion of the distributed electromagnetic radiationdetected by that sensor; generating a signal signature representative ofthe detected electromagnetic radiation; and determining dose informationassociated with the drug based on at least the signal signature.
 70. Themethod of claim 69, further comprising sending, via a communicationsinterface, the dose information to a compute device external to ahousing containing the light source, the light guide, and the pluralityof sensors.
 71. The method of claim 69, wherein the dose informationincludes at least one of: a volume of the drug in the container, avolume of a dose of the drug dispensed from the container, a number ofdoses of the drug in the container, a number of doses of the drugdispensed from the container, a type of the drug, a temperature of thedrug, or an expiration of the drug.
 72. The method of claim 69, whereindetermining the dose information includes comparing the signal signatureto information derived from electromagnetic energy signatures previouslyrecorded for a range of volumes of the drug in the container.